| Abraxane (paclitaxel) | Abraxane (paclitaxel) Pediatric Postmarketing Safety Review | 11/20/2025 |
| ArmonAir Respiclick (fluticasone propionate) | ArmonAir Respiclick (fluticasone propionate) Pediatric Postmarketing Safety Review | 11/20/2025 |
| ArmonAir Digihaler (fluticasone propionate) | ArmonAir Digihaler Pediatric Postmarketing Safety Review | 11/20/2025 |
| Airduo Respiclick (fluticasone propionate and salmeterol xinafoate) | AirDuo Respiclick Pediatric Postmarketing Safety Review | 11/20/2025 |
| AirDuo Digihaler(fluticasone propionate and salmeterol xinafoate) | AirDuo Digihaler(fluticasone propionate and salmeterol xinafoate) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Aubagio (teriflunomide) | Aubagio (teriflunomide) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Austedo (deutetrabenazine) | Austedo (deutetrabenazine) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Brexafemme (ibrexafungerp) | Brexafemme (ibrexafungerp) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Bydureon BCise (exenatide) | Bydureon BCise (exenatide) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Bydureon (exenatide) | Bydureon (exenatide) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Byetta (exenatide) | Byetta (exenatide) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Cibinqo (abrocitinib) tablets | Cibinqo (abrocitinib) tablets Pediatric Postmarketing Safety Review | 11/20/2025 |
| Medtronic Contegra® Pulmonary Valved Conduit | Medtronic Contegra® Pulmonary Valved Conduit Executive Summmary | 11/20/2025 |
| Cosentyx (secukinumab) injection | Cosentyx (secukinumab) injection Pediatric Postmarketing Safety Review | 11/20/2025 |
| Descovy (emtricitabine and tenofovir alafenamide) | Descovy (emtricitabine and tenofovir alafenamide) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Dupixent (dupilumab) | Dupixent (dupilumab) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Edurant (rilpivirine) tablets | Edurant (rilpivirine) tablets Pediatric Postmarketing Safety Review | 11/20/2025 |
| Edurant (rilpivirine) tablets | Edurant (rilpivirine) tablets Pediatric Postmarketing Safety Review | 11/20/2025 |
| Edurant PED (rilpivirine) tablets for suspension | Edurant PED (rilpivirine) tablets for suspension Pediatric Postmarketing Safety Review | 11/20/2025 |
| Enbrel (etanercept) injection | Enbrel (etanercept) injection Pediatric Postmarketing Safety Review | 11/20/2025 |
| Enterra® Therapy System | Enterra® Therapy System Executive Summary | 11/20/2025 |
| Evotaz (atazanavir and cobicistat) | Evotaz (atazanavir and cobicistat) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Lialda (mesalamine) delayed-release tablets | Lialda (mesalamine) delayed-release tablets Pediatric Postmarketing Safety Review | 11/20/2025 |
| Linzess (linaclotide) capsules | Linzess (linaclotide) capsules Pediatric Postmarketing Safety Review | 11/20/2025 |
| Litfulo (ritlecitinib) capsules | Litfulo (ritlecitinib) capsules Pediatric Postmarketing Safety Review | 11/20/2025 |
| Myrbetriq extended-release tablets (mirabegron) | Myrbetriq extended-release tablets (mirabegron) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Myrbetriq granules (mirabegron) | Myrbetriq granules (mirabegron) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Nucynta (tapentadol hydrochloride) | Nucynta (tapentadol hydrochloride) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Nucynta ER (tapentadol hydrochloride) | Nucynta ER (tapentadol hydrochloride) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Opana (oxymorphone hydrochloride immediate-release) | Opana (oxymorphone hydrochloride immediate-release) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Pifeltro (doravirine) | Pifeltro (doravirine) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Delstrigo (doravirine, lamivudine, tenofovir disoproxil fumarate) | Delstrigo (doravirine, lamivudine, tenofovir disoproxil fumarate) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Pleximmune™ | Pleximmune™ Executive Summary | 11/20/2025 |
| Quelimmune | Quelimmune Memorandum | 11/20/2025 |
| Rapivab (peramivir) | Rapivab (peramivir) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Rexulti (brexpiprazole) tablets | Rexulti (brexpiprazole) tablets Pediatric Postmarketing Safety Review | 11/20/2025 |
| Ryaltris (olopatadine hydrochloride and mometasone furoate monohydrate nasal spray) | Ryaltris (olopatadine hydrochloride and mometasone furoate monohydrate nasal spray) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Selzentry (maraviroc) tablets | Selzentry (maraviroc) tablets Pediatric Postmarketing Safety Review | 11/20/2025 |
| Selzentry (maraviroc) oral solution | Selzentry (maraviroc) oral solution Pediatric Postmarketing Safety Review | 11/20/2025 |
| SEVENFACT [coagulation factor VIIa recombinant human-jncw] | SEVENFACT [coagulation factor VIIa recombinant human-jncw] Memorandum | 11/20/2025 |
| Simponi Aria (golimumab) injection | Simponi Aria (golimumab) injection Pediatric Postmarketing Safety Review | 11/20/2025 |
| SMOFlipid (lipid injectable emulsion) for intravenous use | SMOFlipid (lipid injectable emulsion) for intravenous use Pediatric Postmarketing Safety Review | 11/20/2025 |
| Solosec (secnidazole) | Solosec (secnidazole) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Sonalleve MR-HIFU | Sonalleve MR-HIFU Executive Summary | 11/20/2025 |
| Taytulla (norethindrone acetate/ethinyl estradiol capsules and ferrous fumarate capsules) | Taytulla (norethindrone acetate/ethinyl estradiol capsules and ferrous fumarate capsules) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Tezspire (tezepelumab-ekko) injection | Tezspire (tezepelumab-ekko) injection Pediatric Postmarketing Safety Review | 11/20/2025 |
| Trintellix (vortioxetine) tablets | Trintellix (vortioxetine) tablets Pediatric Postmarketing Safety Review | 11/20/2025 |
| VAXCHORA (Cholera Vaccine, Live, Oral) | VAXCHORA (Cholera Vaccine, Live, Oral) Memorandum | 11/20/2025 |
| Viibryd (vilazodone hydrochloride) | Viibryd (vilazodone hydrochloride) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Xofluza (baloxavir marboxil) | Xofluza (baloxavir marboxil) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Ycanth (cantharidin) topical solution | Ycanth (cantharidin) topical solution Pediatric Postmarketing Safety Review | 11/20/2025 |
| Zegalogue (dasiglucagon) | Zegalogue (dasiglucagon) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Zepatier (elbasvir and grazoprevir) | Zepatier (elbasvir and grazoprevir) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Zerbaxa (ceftolozane and tazobactam) | Zerbaxa (ceftolozane and tazobactam) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Zosyn (piperacillin/tazobactam) | Zosyn (piperacillin/tazobactam) Pediatric Postmarketing Safety Review | 11/20/2025 |
| Auvi-Q (epinephrine injection, USP) | Auvi-Q (epinephrine injection, USP) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Dengvaxia (Dengue Tetravalent Vaccine, Live) | Dengvaxia (Dengue Tetravalent Vaccine, Live) Safety and Utilization Review | 7/9/2025 |
| Diovan (valsartan) | Diovan (valsartan) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Entresto (sacubitril and valsartan) | Entresto (sacubitril and valsartan) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Epicel (cultured epidermal autografts) | Epicel (cultured epidermal autografts) Safety and Utilization Review | 7/9/2025 |
| Eraxis (anidulafungin) | Eraxis (anidulafungin) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Eucrisa (crisaborole) | Eucrisa (crisaborole) Pediatric Postmarketing Safety Review | 7/9/2025 |
Exjade (deferasirox), Jadenu (deferasirox), Jadenu Sprinkle
(deferasirox) | Exjade (deferasirox), Jadenu (deferasirox), Jadenu Sprinkle
(deferasirox) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Fiasp (insulin aspart) | Fiasp (insulin aspart) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Fluzone Quadrivalent (Influenza Vaccine) | Fluzone Quadrivalent (Influenza Vaccine) | 7/9/2025 |
| Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) | Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) Safety and Utilization Review | 7/9/2025 |
| Jakafi (ruxolitinib) and Opzeura (ruxolitinib) | Jakafi (ruxolitinib) and Opzeura (ruxolitinib) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Latuda (lurasidone hydrochloride) | Latuda (lurasidone hydrochloride) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Liletta (levonorgestrel-releasing intrauterine system) | Liletta (levonorgestrel-releasing intrauterine system) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Liposorber LA-15 System | Liposorber LA-15 System Executive Summary | 7/9/2025 |
| Medtronic Activa Neurostimulator for Dystonia Treatment | Medtronic Activa Neurostimulator for Dystonia Treatment Executive Summary | 7/9/2025 |
| Minimally Invasive Deformity Correction (MID-C) System | Minimally Invasive Deformity Correction (MID-C) System Executive Summary | 7/9/2025 |
| Mycamine (micafungin for injection) | Mycamine (micafungin for injection) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Nityr (nitisinone) | Nityr (nitisinone) Pediatric Postmarketing Safety Review | 7/9/2025 |
Potassium Phosphates Injection (Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic) - (phosphorus 3 mmol/mL and potassium 4.7 mEq/mL), Potassium Phosphates Injection
(Potassium Phosphate, Dibasic;
Potassium Phosphate, Monobasic) -
(phosphorus 3 mmol/mL and
potassium 4.4 mEq/mL) | Potassium Phosphates Injection (Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic) - (phosphorus 3 mmol/mL and potassium 4.7 mEq/mL), Potassium Phosphates Injection
(Potassium Phosphate, Dibasic;
Potassium Phosphate, Monobasic) -
(phosphorus 3 mmol/mL and
potassium 4.4 mEq/mL) | 7/9/2025 |
| REFLECT Scoliosis Correction System | REFLECT Scoliosis Correction System Executive Summary | 7/9/2025 |
| Repatha (evolocumab) | Repatha (evolocumab) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Rozlytrek (entrectinib) | Rozlytrek (entrectinib) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Stelara (ustekinumab) | Stelara (ustekinumab) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Sutent (sunitinib malate) | Sutent (sunitinib malate) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Tasigna (nilotinib) | Tasigna (nilotinib) Pediatric Postmarketing Safety Review | 7/9/2025 |
| The Tether – Vertebral Body Tethering System | The Tether – Vertebral Body Tethering System Executive Summary | 7/9/2025 |
| Topicort (desoximetasone) | Topicort (desoximetasone) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Triumeq tablet, Triumeq PD (abacavir, dolutegravir, lamivudine) Pediatric Postmarketing Safety Review | Triumeq tablet, Triumeq PD (abacavir, dolutegravir, lamivudine) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Xyrem (sodium oxybate) | Xyrem (sodium oxybate) Pediatric Postmarketing Safety Review | 7/9/2025 |
| Yervoy (Ipilimumab) injection | Yervoy (Ipilimumab) injection Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Xelstrym (dextroamphetamine) transdermal system | Xelstrym (dextroamphetamine) transdermal system Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Xeglyze (abametapir) | Xeglyze (abametapir) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Xaciato (clindamycin phosphate) vaginal gel | Xaciato (clindamycin phosphate) vaginal gel Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Vyvanse (lisdexamfetamine dimesylate) capsule and chewable tablet | Vyvanse (lisdexamfetamine dimesylate) capsule and chewable tablet Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Veklury (remdesivir) | Veklury (remdesivir) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Tybost (cobicistat) | Tybost (cobicistat) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Selenious acid injection (selenious acid) intravenous solution | Selenious acid injection (selenious acid) intravenous solution Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Zinc sulfate injection intravenous solution | Zinc sulfate injection intravenous solution Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Tralement (trace elements injection 4) intravenous solution | Tralement (trace elements injection 4) intravenous solution Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Multrys (trace elements injection 4) intravenous solution | Multrys (trace elements injection 4) intravenous solution Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Tirosint-SOL (Levothyroxine sodium) oral solution | Tirosint-SOL (Levothyroxine sodium) oral solution Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Teflaro® | Teflaro® (ceftaroline fosamil) for injection Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Riomet ER (metformin hydrochloride for extended-release oral suspension) | Riomet ER (metformin hydrochloride for extended-release oral suspension) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Qelbree (viloxazine extended-release capsules) | Qelbree (viloxazine extended-release capsules) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Pradaxa (dabigatran etexilate) capsule and oral pellet | Pradaxa (dabigatran etexilate) capsule and oral pellet Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Natroba (spinosad) topical suspension | Natroba (spinosad) topical suspension Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Mydayis (mixed salts of a single-entity amphetamine product) extended-release capsules | Mydayis (mixed salts of a single-entity amphetamine product)
extended-release capsules Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Mircera (methoxy polyethylene glycol-epoetin beta) injection | Mircera (methoxy polyethylene glycol-epoetin beta) injection Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Mavyret (glecaprevir/pibrentasvir) | Mavyret (glecaprevir/pibrentasvir) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Lumason (sulfur hexafluoride lipid-type A microspheres) | Lumason (sulfur hexafluoride lipid-type A microspheres) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Lotemax (loteprednol etabonate ophthalmic gel) 0.5% | Lotemax (loteprednol etabonate ophthalmic gel) 0.5% Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Lithium | Lithium Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Ultravate (halobetasol propionate) lotion | Ultravate (halobetasol propionate) lotion Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Lexette (halobetasol propionate) topical foam | Lexette (halobetasol propionate) topical foam Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Kapspargo Sprinkle (metoprolol succinate) extended-release capsule | Kapspargo Sprinkle (metoprolol succinate) extended-release capsule Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Januvia (sitagliptin) | Januvia (sitagliptin) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Janumet (sitagliptin and metformin hydrochloride) | Janumet (sitagliptin and metformin hydrochloride) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Janumet XR (Sitagliptin and metformin hydrochloride extended-release) | Janumet XR (sitagliptin and metformin hydrochloride extended-release) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Gilenya (fingolimod) capsules | Gilenya (fingolimod) capsules Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Tascenso ODT (fingolimod) orally disintegrating tablet | Tascenso ODT (fingolimod) orally disintegrating tablet Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Gattex (teduglutide) | Gattex (teduglutide) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Evekeo ODT (amphetamine sulfate) orally disintegrating tablets | Evekeo ODT (amphetamine sulfate) orally disintegrating tablets Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Sonalleve MR-HIFU | Sonalleve MR-HIFU Executive Summary | 9/26/2024 |
| Cutaquig (Immune Globulin Subcutaneous (Human) - hipp) | Cutaquig (Immune Globulin Subcutaneous (Human) - hipp) Safety and Utilization Review | 9/26/2024 |
| Agriflu (Influenza Virus Vaccine) | Agriflu (Influenza Virus Vaccine) Safety and Utilization Review | 9/26/2024 |
| PulseRider Aneurysm Neck Reconstruction Device (H160002) | PulseRider Aneurysm Neck Reconstruction Device (H160002) Executive Summary | 9/26/2024 |
| Pleximmune™ (H130004) | Pleximmune™ (H130004) Executive Summary | 9/26/2024 |
| Xyntha (Antihemophilic Factor (Recombinant), Plasma/Albumin Free) | Xyntha (Antihemophilic Factor (Recombinant), Plasma/Albumin Free) Safety and Utilization Review | 9/26/2024 |
| Flourish™ Pediatric Esophageal Atresia Device (H150003) | Flourish™ Pediatric Esophageal Atresia Device (H150003) Executive Summary | 9/26/2024 |
| Enterra® Therapy System (H990014) | Enterra® Therapy System (H990014) Executive Summary | 9/26/2024 |
| Dyanavel XR (amphetamine) extended-release tablet | Dyanavel XR (amphetamine) extended-release tablet Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Medtronic Contegra® Pulmonary Valved Conduit Models 200 (unsupported) and 200S (supported) (H020003) | Medtronic Contegra® Pulmonary Valved Conduit Models 200 (unsupported) and 200S (supported) (H020003) Executive Summary | 9/26/2024 |
| Cleocin hydrochloride (clindamycin hydrochloride) | Cleocin hydrochloride (clindamycin hydrochloride) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Cleocin phosphate (clindamycin phosphate) | Cleocin phosphate (clindamycin phosphate) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
Cleocin phosphate in dextrose 5% in plastic container (clindamycin
phosphate) | Cleocin phosphate in dextrose 5% in plastic container (clindamycin phosphate) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
Clindamycin phosphate in 0.9% sodium chloride (clindamycin
phosphate) | Clindamycin phosphate in 0.9% sodium chloride (clindamycin phosphate) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Cimduo (lamivudine\tenofovir disoproxil fumarate) | Cimduo (lamivudine\tenofovir disoproxil fumarate) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Temixys (lamivudine\tenofovir disoproxil fumarate) | Temixys (lamivudine\tenofovir disoproxil fumarate) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Chantix (varenicline tartrate) tablets | Chantix (varenicline tartrate) tablets Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Cafcit injection (caffeine citrate injection, USP) | Cafcit injection (caffeine citrate injection, USP) Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Azstarys (serdexmethylphenidate and dexmethylphenidate) capsules | Azstarys (serdexmethylphenidate and dexmethylphenidate) capsules Pediatric Postmarketing Pharmacovigilance Review | 9/26/2024 |
| Epicel (cultured epidermal autografts) | Epicel (cultured epidermal autografts) Memorandum | 5/9/2024 |
| Liposorber LA-15 System | Liposorber LA-15 System Executive Summary | 5/9/2024 |
| The Tether - Vertebral Body Tethering System | The Tether - Vertebral Body Tethering System Executive Summary | 5/9/2024 |
| Medtronic Activa Neurosimulator for Dystonia Treatment | Medtronic Activa Neurosimulator for Dystonia Treatment Executive Summary | 5/9/2024 |
| Minimally Invasive Deformity Correction (MID-C) System | Minimally Invasive Deformity Correction (MID-C) System Executive Summary | 5/9/2024 |
| Isentress (raltegravir potassium) | Isentress Safety and Utilization Review | 09/12/2016 |
| Lysteda (tranexamic acid) | Lysteda Safety and Utilization Review | 09/12/2016 |
| Salonpas Relief (methyl salicylate 10% and 1-menthol 3%P Patch) | Salonpas Relief Safety and Utilization Review | 09/12/2016 |
| Aleve PM® (naproxen sodium 220 mg and diphenhydramine hydrochloride 25 mg) | Aleve PM® Safety and Utilization Review | 02/03/2017 |
| Astepro (azelastine hydrochloride) | Astepro Safety and Utilization Review | 02/03/2017 |
| Jetrea® (ocriplasmin) Intravitreal Injection | Jetrea® Safety and Utilization Review | 02/03/2017 |
| Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets, for oral use) | Quartette Safety and Utilization Review | 02/03/2017 |
| Spectazole (econazole nitrate) cream, 1% Ecoza (econazole nitrate) topical foam, 1% | Spectazole/Ecoza Safety and Utilization Review | 02/03/2017 |
| Truvada® (emtricitabine and tenofovir disoproxil fumarate) | Truvada® Safety and Utilization Review | 02/03/2017 |
| Xerese® (5% acyclovir and 1% hydrocortisone cream) | Xerese® Safety and Utilization Review | 02/03/2017 |
| Aloxi (palonosetron hydrochloride) | Aloxi Safety and Utilization Review | 08/04/2017 |
| Arnuity Ellipta (fluticasone furoate) | | 08/04/2017 |
| Asmanex HFA and Asmanex Twisthaler (mometasone furoate inhalation) | Asmanex HFA and Asmanex Twisthaler Safety and Utilization Review | 08/04/2017 |
| Cymbalta (duloxetine) | Cymbalta Safety and Utilization Review | 08/04/2017 |
| Emsam (selegiline transdermal system) | Emsam Safety and Utilization Review | 08/04/2017 |
| GRASTEK® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use | GRASTEK Safety and Utilization ReviewFDA Drug Utilization Information on GRASTEK and ORALAIR | 08/04/2017 |
| Latisse® (bimatoprost ophthalmic solution) 0.03% | Latisse® Safety and Utilization Review | 08/04/2017 |
| Namenda and Namenda XR extended-release (memantine hydrochloride) | Namenda and Namenda XR Safety and Utilization Review | 08/04/2017 |
| ORALAIR (Sweet Vernal, Orchard Perennial rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for sublingual Use | ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and
Kentucky Blue Grass Mixed Pollens Allergen Extract)
Tablet for Sublingual Use MemorandumK and ORALAIR | 08/04/2017 |
| Priftin® (rifapentine) | Priftin® Safety and Utilization Review | 08/04/2017 |
| Reyataz® (atazanavir) | Reyataz® Safety and Utilization Review | 08/04/2017 |
| Taclonex (betamethasone dipropionate/calcipotriene hydrate) 0.064%/0.005% | Taclonex Safety and Utilization Review | 08/04/2017 |
| Zetonna (ciclesonide) | Zetonna (ciclesonide) Safety and Utilization Review | 08/04/2017 |
| Dymista (azelastine hydrochloride fluticasone propionate) | Dymista (azelastine hydrochloride fluticasone propionate) Pediatric Safety Review | 01/07/2018 |
| Edurant (rilpivirine) Complera and Odefsey | Edurant (rilpivirine) Complera and Odefsey Pediatric Safety Review | 01/07/2018 |
| Merrem IV (meropenem) | Merrem IV (meropenem) Pediatric Safety Review | 01/07/2018 |
| Naftin (nafifine hydrochloride) | Naftin (nafifine hydrochloride) Pediatric Safety and Drug Utilization Review | 01/07/2018 |
| OTIPRO (ciprofloxacin otic suspension) | OTIPRO (ciprofloxacin otic suspension) Pediatric Safety Review | 01/07/2018 |
| PAZEO (olopatadine hydrochloride ophthalmic solution) | PAZEO (olopatadine hydrochloride ophthalmic solution) Pediatric Safety Review | 01/07/2018 |
| QNASL beclomethasone dipropionate) nasal aerosol | QNASL beclomethasone dipropionate) nasal aerosol Safety Review | 01/07/2018 |
| Treximet (naproxen sodium sumatriptan succinate) | Treximet (naproxen sodium sumatriptan succinate) Safety Review | 01/07/2018 |
| Valcyte (valganciclovir) | Valcyte (valganciclovir) Safety Review | 01/07/2018 |
| Atropine Sulfate Ophthalmic Solution, USP 1% | Atropine Sulfate Ophthalmic Solution, USP 1% Pediatric Postmarketing Pharmacovigilance Review | 03/05/2018 |
| Emend (aprepitant) Capsule and Oral Suspension | Emend (aprepitant) Capsule and Oral Suspension Pediatric Safety Review | 03/05/2018 |
| Epicel (cultured epidermal autografts) | Epicel (cultured epidermal autografts) Executive Summary, Pediatric Safety Update | 03/05/2018 |
| Epiduo Forte (adapalene/benzoyl peroxide, 0.3%/2.5%) gel | Epiduo Forte (adapalene/benzoyl peroxide, 0.3%/2.5%) gel Pediatric Safety Review | 03/05/2018 |
| Flourish Pediatric Esophageal Atresia Device | Flourish 2018 Executive Summary | 03/05/2018 |
| Gadavist (gadobutrol), Eovist or Primovist (gadoxetate disodium) | Gadavist (gadobutrol) Eovist or Primovist (gadoxetate disodium) Pediatric Safety Review | 03/05/2018 |
| Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) | Gardasil 9 Pediatric Safety and Utilization Review | 03/05/2018 |
| Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) oral tablets | Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) oral tablets Pediatric Safety Review | 03/05/2018 |
| Kapvay (clonidine extended-release) tablets | Kapvay® (clonidine extended-release) tablets Pediatric Safety and Drug Utilization Review | 03/05/2018 |
| Nucala (mepolizumab) | Nucala (mepolizumab) Pediatric Safety Review | 03/05/2018 |
| Saphris (asenapine) | Saphris (asenapine) Pediatric Safety Review | 03/05/2018 |
| Tivicay (dolutegravir) | Tivicay (dolutegravir) Pediatric Safety Review | 03/05/2018 |
| Trumenba Meningococcal Group B Vaccine | Trumenba Pediatric Pediatric Safety Review | 03/05/2018 |
| Banzel (rufinamide) | Banzel (rufinamide) Pediatric Safety Review Banzel (rufinamide) Pediatric Utilization Review | 04/25/2018 |
| Liposorber LA-15 System | Liposorber LA-15 System 2018 Executive Summary | 04/25/2018 |
| Medtronic Activa Dystonia Therapy | Medtronic Activa Dystonia Therapy 2018 Executive Summary | 04/25/2018 |
| Adzenys XR and Dyanavel XR (amphetamine) | Dyanavel Pediatric Safety Review | 06/13/2018 |
| Anthim (obiltoxaximab) | Anthim Pediatric Safety Review | 06/13/2018 |
| Aptensio XR and Quillichew (methylphenidate hydrochloride) | Aptensio XR and Quillichew ER Pediatric Safety Review | 06/13/2018 |
| Cinqair (reslizumab) | Cinqair Pediatric Safety Review | 06/13/2018 |
| Cutivate (fluticasone propionate) | Cutivate Pediatric Safety Review | 06/13/2018 |
| Descovy (emtricitabine and tenofovir alafenamide) | Descovy Pediatric Safety Review | 06/13/2018 |
| Epivir (lamivudine) | Epivir Pediatric Safety Review | 06/13/2018 |
| Kaletra (lopinavir and ritonavir) | Kaletra Pediatric Safety Review | 06/13/2018 |
| Natroba (spinosad) | Natroba Pediatric Safety Review | 06/13/2018 |
| Noxafil (posaconazole) | Noxafil Pediatric Safety Review | 06/13/2018 |
| Oraltag (iohexol) | Oraltag Pediatric Safety Review | 06/13/2018 |
| Otovel Otic Solution (ciprofloxacin and fluocinolone acetonide) | Ovotel Pediatric Safety Review | 06/13/2018 |
| Prilosec (omeprazole) | Prilosec Pediatric Safety Review | 06/13/2018 |
| ProAir RespiClick (abuterol sulfate) | ProAir Respiclick Pediatric Safety Review | 06/13/2018 |
| Procysbi (cysteamine bitartrate) | Procysbi Pediatric Safety Review | 06/13/2018 |
| Teflaro Injection (ceftaroline fosamil) | Teflaro Pediatric Safety Review | 06/13/2018 |
| Tetracaine Hydrochloride Ophthalmic Solution (tetracaine hydrochloride) | Tetracaine Pediatric Safety Review | 06/13/2018 |
| Xopenex HFA Inhalation Aerosol (levalbuterol) | Xopenex Pediatric Safety Review | 06/13/2018 |
| Bexsero (Meningococcal Group B Vaccine) | Bexsero Safety Review | 09/12/2018 |
| Contegra Pulmonary Valved Conduit (Humanitarian Device Exemption [HDE]) | Contegra 2018 Executive Summary | 09/12/2018 |
| Elana Surgical Kit (HDE) | Elana Surgical Kit 2018 Executive Summary | 09/12/2018 |
| Enterra Therapy System (HDE) | Enterra 2018 Executive Summary | 09/12/2018 |
| Entocort EC (budesonide) | Entocort EC Safety Review | 09/12/2018 |
| Epzicom (abacavir sulfate and lamivudine) and Ziagen (abacavir sulfate) | Epzicom and Ziagen Safety Review | 09/12/2018 |
| Kovanaze (tetracaine HCl and oxymetazoline HCl) | Kovanaze Safety Review | 09/12/2018 |
| Lamictal (lamotrigine) | Lamictal Safety Review | 09/12/2018 |
| Oraverse (phentolamine mesylate) | Oraverse Safety Review | 09/12/2018 |
| Pancreaze & Pertzye (pancrelipase) | Pancreaze & Pertzye Safety Review | 09/12/2018 |
| Pleximmune™ in-vitro diagnostic test (HDE) | Pleximmune™2018 Executive Summary | 09/12/2018 |
| PulseRider Aneurysm Neck Reconstruction Device (HDE) | PulseRider 2018 Executive Summary | 09/12/2018 |
| Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) | Quadracel Safety Review | 09/12/2018 |
| Renvela (sevelamer carbonate) | Renvela Safety Review | 09/12/2018 |
| Zomig Nasal Spray (zolmitriptan) | Zomig Nasal Spray Safety Review | 09/12/2018 |
| Aczone (dapsone) gel, 7.5% | Aczone Safety Review | 03/28/2019 |
| Adynovate | Adynovate Safety Review | 03/28/2019 |
| AirDuo RespiClick (fluticasone propionate and salmeterol xinafoate) ArmonAir RespiClick (fluticasone propionate) | AirDuo Respiclick and ArmonAir Respiclick Safety Review | 03/28/2019 |
| Avelox (moxifloxacin, tablets and injection) | Avelox Safety Review | 03/28/2019 |
| Caldolor (ibuprofen) IV injection | Caldolor Safety Review | 03/28/2019 |
| Cubicin® and Cubicin® RF (daptomycin for injection) | Cubicin Safety Review | 03/28/2019 |
| Dexilant, Dexilant SoluTab (dexlansoprazole) | Dexilant Safety Review | 03/28/2019 |
| Epicel (cultured epidermal autografts) | Epicel 2019 Executive Summary | 03/28/2019 |
| Eucrisa (crisaborole) ointment, 2% | Eucrisa Safety Review | 03/28/2019 |
| Flourish™ Pediatric Esophageal Atresia Device | Flourish 2019 Executive Summary | 03/28/2019 |
| IXINITY [Coagulation Factor IX (Recombinant)] | IXINITY Safety Review | 03/28/2019 |
| Liletta (levonorgestrel-releasing intrauterine system) | Liletta Safety Review | 03/28/2019 |
| Liposorber® LA-15 System | Liposorber 2019 Executive Summary | 03/28/2019 |
| Lyrica (pregabalin) | Lyrica Safety Review | 03/28/2019 |
| Medtronic Activa Neurostimulator for Dystonia Treatment | Medtronic Activa 2019 Executive Summary | 03/28/2019 |
| Narcan (naloxone) nasal spray | Narcan Safety Review | 03/28/2019 |
| Ofirmev (acetaminophen) injection | Ofirmev Safety Review | 03/28/2019 |
| Selzentry (maraviroc) | Selzentry Safety Review | 03/28/2019 |
| Spiriva Respimat (tiotropium bromide) | Spiriva Safety Review | 03/28/2019 |
| Symbicort (budesonide/ formoterol fumarate dihydrate) | Symbicort Safety Review | 03/28/2019 |
| Tarceva™ (erlotinib) | Tarceva Safety Review | 03/28/2019 |
| Velcade® (bortezomib) | Velcade Safety Review | 03/28/2019 |
| Ativan injection (lorazepam injection) | Ativan Pediatric Safety Review | 09/19/2019 |
| Calcium gluconate injection (calcium gluconate) | Calcium Gluconate Pediatric Safety Review | 09/19/2019 |
| Cerebyx® (fosphenytoin sodium) | Cerebyx® Pediatric Safety Review | 09/19/2019 |
| Contegra Pulmonary Valved Conduit (Humanitarian Device Exemption [HDE]) | Contegra 2019 Executive Summary | 09/19/2019 |
| Dotarem (gadoterate meglumine) | Dotarem Pediatric Safety Review | 09/19/2019 |
| E-Z-HD (barium sulfate) | Barium Sulfate Pediatric Safety Review | 09/19/2019 |
| Elana Surgical Kit (HDE) | Elana Surgical Kit 2019 Executive Summary | 09/19/2019 |
| Enterra Therapy System (HDE) | Enterra Therapy System 2019 Executive Summary | 09/19/2019 |
| Fycompa oral tablets and suspension (perampanel) | Fycompa Pediatric Safety Review | 09/19/2019 |
| Gammaplex - Immune Globulin Intravenous (Human) 5% Liquid | Gammaplex Safety and Utilization Review | 09/19/2019 |
| Harvoni (ledipasvir and sofosbuvir) | Harvoni Pediatric Safety Review | 09/19/2019 |
| Isentress and Isentress HD (raltegravir) | Isentress and Isentress HD Pediatric Safety Review | 09/19/2019 |
| Latuda (lurasidone hydrochloride) | Latuda Pediatric Safety Review | 09/19/2019 |
| Liquid E-Z-Paque (barium sulfate) | Barium Sulfate Pediatric Safety Review | 09/19/2019 |
| NUWIQ® (simoctocog alfa) | NUWIQ® Safety and Utilization Review | 09/19/2019 |
| Pleximmune™ in-vitro diagnostic test (HDE) | Pleximmune™ 2019 Executive Summary | 09/19/2019 |
| PulseRider Aneurysm Neck Reconstruction Device (HDE) | PulseRider 2019 Executive Summary | 09/19/2019 |
| Rapivab® (peramivir) | Rapivab® Pediatric Safety Review | 09/19/2019 |
| Readi-Cat 2, Readi-Cat 2 smoothies (barium sulfate) | Barium Sulfate Pediatric Safety Review | 09/19/2019 |
| Ryzodeg 70/30 (insulin degludec and insulin aspart injection) for subcutaneous use 100 units/mL (U-100) in 3mL FlexTouch Pen | Ryzodeg Pediatric Safety Review | 09/19/2019 |
| Simponi (golimumab SC), Simponi Aria (golimumab IV) | Simponi Pediatric Safety Review | 09/19/2019 |
| Sovaldi (sofosbuvir) | Sovaldi Pediatric Safety Review | 09/19/2019 |
| Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) | Stribild Pediatric Safety Review | 09/19/2019 |
| TACHOSIL (Fibrin Sealant Patch) | TACHOSIL Safety and Utilization Review | 09/19/2019 |
| Tresiba (insulin degludec injection) for subcutaneous use, 100 units/mL (U-100) in 3mL single-patient-use FlexTouch Pen; 200 units/mL (U-200) in 3mL single-patient-use FlexTouch Pen; 100 units/mL (U-100) 10 mL in multiple-dose vial | Tresiba Pediatric Safety Review | 09/19/2019 |
| Varibar pudding (barium sulfate) | Barium Sulfate Pediatric Safety Review | 09/19/2019 |
| Vigamox (moxifloxacin hydrochloride ophthalmic solution 0.5%) | Vigamox Pediatric Safety Review | 09/19/2019 |
| Visipaque injection (iodixanol) | Visipaque Pediatric Safety Review | 09/19/2019 |
| WILATE (von Willebrand Factor/ Coagulation Factor VIII Complex (Human)) | WILATE Safety and Utilization Review | 09/19/2019 |
| Zemplar (paricalcitol) | Zemplar Pediatric Safety Review | 09/19/2019 |
| Zymar® 0.3% (gatifloxacin ophthalmic solution) | Zymar® Pediatric Safety Review | 09/19/2019 |
| AFSTYLA (antihemophilic factor (recombinant), single chain) | AFSTYLA Safety and Utilization Review | 07/13/2020 |
| Butrans (buprenorphine transdermal system) | Butrans Pediatric Safety and Utilization Review | 07/13/2020 |
| DraxImage DTPA (technetium TC-99m pentetate kit) injection and inhalation | DraxImage DTPA Pediatric Safety Review | 07/13/2020 |
| Dysport (AbobotulinumtoxinA) | Dysport Pediatric Safety Review | 07/13/2020 |
| Epicel (cultured epidermal autografts) | Epicel 2020 Executive Summary | 07/13/2020 |
| KOVALTRY (antihemophilic factor (recombinant)) | KOVALTRY Safety and Utilization Review | 07/13/2020 |
| Liposorber® LA-15 System (HDE) | Liposorber® LA-15 System 2020 Executive Summary | 07/13/2020 |
| Lumason (sulfur hexafluoride lipid-type A microspheres) injectable suspension | Lumason Pediatric Safety Review | 07/13/2020 |
| Medtronic Activa® Dystonia Therapy (HDE) | Medtronic Activa® Dystonia Therapy 2020 Executive Summary | 07/13/2020 |
| Omidria (phenylephrine and ketorolac intraocular solution) | Omidria Pediatric Safety Review | 07/13/2020 |
| Stelara (ustekinumab) injection | Stelara Pediatric Safety Review | 07/13/2020 |
| Symfi Lo™ (efavirenz 400mg + lamivudine 300mg + tenofovir disoproxil fumarate 300mg) and Symfi™ (efavirenz 600mg + lamivudine 300mg + tenofovir disoproxil fumarate 300mg) | Symfi Lo™ and Symfi™ Pediatric Safety Review | 07/13/2020 |
| Canasa (mesalamine suppositories for rectal use) | Canasa Pediatric Safety Review | 09/01/2020 |
| Contegra Pulmonary Valved Conduit (HDE) | Contegra Pulmonary Valved Conduit Executive Summary | 09/01/2020 |
| Descovy® (emtricitabine and tenofovir alafenamide) | Descovy® Pediatric Safety Review | 09/01/2020 |
| Elana Surgical Kit (HDE) | Elana Surgical Kit Executive Summary | 09/01/2020 |
| Enterra Therapy System (HDE) | Enterra Therapy System Executive Summary | 09/01/2020 |
| Flucelvax (influenza vaccine) | Flucelvax Safety and Utilization Review | 09/01/2020 |
| Flucelvax Quadrivalent (influenza vaccine) | Flucelvax Quadrivalent Safety and Utilization Review | 09/01/2020 |
| FluLaval (influenza vaccine) | FluLaval Safety and Utilization Review | 09/01/2020 |
| FluLaval Quadrivalent (influenza vaccine) | FluLaval Quadrivalent Safety and Utilization Review | 09/01/2020 |
| Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir | Genvoya® Pediatric Safety Review | 09/01/2020 |
| Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] | Hiberix Safety and Utilization Review | 09/01/2020 |
| Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted | Influenza A (H5N1) Virus Monovalent Vaccine Safety and Utilization Review | 09/01/2020 |
| Lumify (brimonidine tartrate) OTC | Lumify Pediatric Safety Review | 09/01/2020 |
| Luzu (luliconazole) cream, 1% | Luzu Pediatric Safety Review | 09/01/2020 |
| Pleximmune™ in-vitro diagnostic test (HDE) | Pleximmune™ in-vitro diagnostic test Executive Summary | 09/01/2020 |
| PulseRider Aneurysm Neck Reconstruction Device (HDE) | PulseRider Aneurysm Neck Reconstruction Device Executive Summary | 09/01/2020 |
| Sensipar (cinacalcet) | Sensipar Pediatric Safety Review | 09/01/2020 |
| Triumeq (abacavir, dolutegravir, and lamivudine) | Triumeq Pediatric Safety Review | 09/01/2020 |
| Xepi (ozenoxacin) | Xepi Pediatric Safety Review | 09/01/2020 |
| Aptiom (eslicarbazepine acetate) | Aptiom Pediatric Postmarketing Pharmacovigilance Review | 04/26/2021 |
| Cotempla XR-ODT (methylphenidate extended release orally disintegrating tablets) | Cotempla Pediatric Postmarketing Pharmacovigilance Review | 04/26/2021 |
| Cuvitru, Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution | Cuvitru Safety and Utilization Review | 04/26/2021 |
| Epicel (cultured epidermal autografts) | Epicel Safety Update | 04/26/2021 |
| JIVI (Antihemophilic Factor (Recombinant), PEGylated-aucl) | JIVI Safety and Utilization Review | 04/26/2021 |
| Liposorber® LA-15 System | Liposorber® LA-15 System Executive Summary | 04/26/2021 |
| Medtronic Activa® Dystonia Therapy (HDE) | Medtronic Activa® Dystonia Therapy Executive Summary | 04/26/2021 |
| Minimally Invasive Deformity Correction (MID-C) System | Minimally Invasive Deformity Correction (MID-C) System Executive Summary | 04/26/2021 |
| Pegasys (peginterferon alpha-2a) | Pegasys Pediatric Postmarketing Pharmacovigiliance Review | 04/26/2021 |
| REBINYN (nonacog beta pegol (N9-GP)) | REBINYN Safety and Utilization Review | 04/26/2021 |
| The Tether™ – Vertebral Body Tethering System | The Tether™ – Vertebral Body Tethering System Executive Summary | 04/26/2021 |
| Vimovo (naproxen/esomeprazole magnesium) | Vimovo Pediatric Postmarketing Pharmacovigilance Review | 04/26/2021 |
| Cialis (tadalafil) | Cialis Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 |
| Elana Surgical Kit (HDE) | Elana Surgical Kit Executive Summary | 09/03/2021 |
| Emend (fosaprepitant dimeglumine) | Emend Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 |
| Enbrel (etanercept), Erelzi (etanercept-szzs), Eticovo (etanercept-ykro) | Enbrel Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 |
| Enterra Therapy System (HDE) | Enterra Therapy System Executive Summary | 09/03/2021 |
| Fasenra (benralizumab) | Fasenra Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 |
| Intelence (etravirine) | Intelence Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 |
| Medtronic Contegra Pulmonary Valved Conduit (HDE) | Medtronic Contegra Pulmonary Valved Conduit Executive Summary | 09/03/2021 |
| Pleximmune™ in-vitro diagnostic test (HDE) | Pleximmune Executive Summary | 09/03/2021 |
| PulseRider Aneurysm Neck Reconstruction Device (HDE) | PulseRider Aneurysm Neck Reconstruction Device Executive Summary | 09/03/2021 |
| RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) | Rotateq Safety and Utilization Review | 09/03/2021 |
| Rubber Panel T.R.U.E. TEST (Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test) | Rubber Panel T.R.U.E. TEST Safety and Utilization Review | 09/03/2021 |
| T.R.U.E. TEST (Thin-Layer Rapid Use Epicutaneous Patch Test) | T.R.U.E. TEST Safety and Utilization Review | 09/03/2021 |
| Tekturna (aliskiren hemifumarate) | Tekturna Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 |
| Viread (tenofovir disoproxil fumarate) | Viread Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 |
| Xofluza (baloxavir marboxil) | Xofluza Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 |
| Actemra (tocilizumab) | Actemra Pediatric Postmarketing Pharmacoviligalance Review | 4/19/2022 |
| Activa Dystonia Therapy (none) | Medtronic Activa Neurostimulator for Dystonia Treatment Executive Summary | 4/25/2022 |
| Amitiza (lubiprostone) | Amitiza Pediatric Postmarketing Pharmacovigilance Review | 4/25/2022 |
| Epicel (cultured epidermal autografts) | Epicel (cultured epidermal autografts) Safety Update Memorandum | 4/25/2022 |
| ESPEROCT (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei) | ESPEROCT (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei) Safety Update Memorandum | 4/25/2022 |
| Liposorber LA-15 System (none) | Liposorber LA-15 System Executive Summary | 4/25/2022 |
| Mavyret (glecaprevir/pibrentasvir) | Mavyret (glecaprevir/pibrentasvir) Pediatric Postmarketing Pharmacovigilance Review | 4/25/2022 |
| Minimally Invasive Deformity Correction (MID-C) System (none) | Minimally Invasive Deformity Correction (MID-C) System (none) Executive Summary | 4/25/2022 |
| PANZYGA (Immune Globulin Intravenous, human-ifas) | PANZYGA (Immune Globulin Intravenous, human-ifas) Safety Update Memorandum | 4/25/2022 |
| Pristiq (desvenlafaxine) | Pristiq (desvenlafaxine) Pediatric Postmarketing Pharmacovigilance Review | 4/25/2022 |
| Slynd (drospirenone) | Slynd (drospirenone) Pediatric Postmarketing Pharmacovigilance Review | 4/25/2022 |
| The Tether - Vertebral Body Tethering System (none) | The Tether - Vertebral Body Tethering System (none) Executive Summary | 4/25/2022 |
| Xembify (immune globulin subcutaneous, human – klhw) | Xembify (immune globulin subcutaneous, human – klhw) Safety Update Memorandum | 4/25/2022 |
| Xolair (omalizumab) | Xolair (omalizumab) Pediatric Postmarketing Pharmacovigilance Review | 4/25/2022 |
| Asceniv (Immune Globulin Intravenous (Human), 10% Liquid) | Asceniv (Immune Globulin Intravenous (Human), 10% Liquid) Safety Update Memorandum | 8/18/2022 |
| Benlysta (belimumab) | Benlysta (belimumab) Pediatric Postmarketing Pharmacovigilance Review | 8/18/2022 |
| Contegra (none) | Medtronic Contegra Pulmonary Valved Circuit Models 200 and 200s Executive Summary | 8/18/2022 |
| Enterra Gastric Electrical Stimulator (none) | Enterra Therapy System Executive Summary | 8/18/2022 |
| FIBRYGA (Fibrinogen (Human)) | FIBRYGA (Fibrinogen (Human)) Safety Update Memorandum | 8/18/2022 |
| Flourish Pediatric Esophageal Atresia Device (none) | Flourish Pediatric Esophageal Atresia Device Executive Summary | 8/18/2022 |
| Pleximmune (none) | Pleximmune Executive Summary | 8/18/2022 |
| PulseRider Aneurysm Neck Reconstruction Device (none) | PulseRider Aneurysm Neck Reconstruction Device Executive Summary | 8/18/2022 |
| Sonalleve MR-HIFU (None) | Sonalleve MR-HIFU Executive Summary | 8/18/2022 |
| Vfend (voriconazole) | Vfend (voriconazole) Pediatric Postmarketing Pharmacovigilance Review | 8/18/2022 |
| Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) | Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) Safety Update Memorandum | 8/18/2022 |
| Mavyret (glecaprevir/pibrentasvir) | Mavyret (glecaprevir/pibrentasvir) Pediatric Postmarketing Pharmacovigilance Review | 9/22/2022 |
| Actemra (tocilizumab) | Actemra (tocilizumab) Actemra Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Actemra (tocilizumab) | Actemra (tocilizumab) Actemra Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Activa Dystonia Therapy (none) | Activa Dystonia Therapy Executive Summary | 4/19/2023 |
| AFLURIA; AFLURIA QUADRIVALENT (Influenza Vaccine) | AFLURIA; AFLURIA QUADRIVALENT (Influenza Vaccine) Safety Update Memorandum | 4/19/2023 |
| Altreno lotion (tretinoin) | Altreno lotion (tretinoin) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Arnuity Ellipta (fluticasone furoate) | Arnuity Ellipta (fluticasone furoate) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Astagraf XL (tacrolimus) | Astagraf XL (tacrolimus) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Avycaz (ceftazidime/avibactam) | Avycaz (ceftazidime/avibactam) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Botox (onabotulinumtoxinA) | Botox (onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Botox (onabotulinumtoxinA) | Botox (onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Botox (onabotulinumtoxinA) | Botox (onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Botox injection (onabotulinumtoxinA) | Botox injection (onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Botox injection (onabotulinumtoxinA) | Botox injection (onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Breo Ellipta (fluticasone furoate/vilanterol) | Breo Ellipta (fluticasone furoate/vilanterol) Safety Update Memorandum | 4/19/2023 |
| Briviact (brivaracetam) | Briviact (brivaracetam) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Briviact tablets, solution, and injection (brivaracetam) | Briviact tablets, solution, and injection (brivaracetam) Safety Update Memorandum | 4/19/2023 |
| Clenpiq (sodium picosulfate/magnesium oxide/anhydrous citric acid) | Clenpiq (sodium picosulfate/magnesium oxide/anhydrous citric acid) Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Corlanor Oral Solution (ivabradine) | Corlanor Oral Solution Executive Summary | 4/19/2023 |
| Cystadrops ophthalmic solution (cysteamine) | Cystadrops ophthalmic solution (cysteamine) Safety Update Memorandum | 4/19/2023 |
| Descovy (emtricitabine/tenofovir alafenamide) | Descovy (emtricitabine/tenofovir alafenamide) Safety Update Memorandum | 4/19/2023 |
| Dysport (abobotulinumtoxinA) | Dysport (abobotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Effient (prasugrel) | Effient (prasugrel) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Epicel (cultured epidermal autografts) | Epicel (cultured epidermal autografts) Safety Update Memorandum | 4/19/2023 |
| Fluarix Quadrivalent (Influenza Vaccine) | Fluarix Quadrivalent (Influenza Vaccine) Safety Update Memorandum | 4/19/2023 |
| Fycompa (perampanel) | Fycompa (perampanel) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Granix injection (tbo-filgrastim) | Granix injection (tbo-filgrastim) Safety Update Memorandum | 4/19/2023 |
| Harvoni (ledipasvir/sofosbuvir) | Harvoni (ledipasvir/sofosbuvir) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Jornay PM (methylphenidate) | Jornay PM (methylphenidate) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Katerzia oral suspension (amlodipine benzoate) | Katerzia oral suspension (amlodipine benzoate) Safety Update Memorandum | 4/19/2023 |
| Kerydin topical solution (tavaborole) | Kerydin topical solution (tavaborole) Safety Update Memorandum | 4/19/2023 |
| Liposorber LA-15 System (none) | Liposorber LA-15 System Executive Summary | 4/19/2023 |
| Livalo (pitavastatin) | Livalo (pitavastatin) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Lyrica (pregabalin) | Lyrica (pregabalin) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Minimally Invasive Deformity Correction (MID-C) System (none) | Minimally Invasive Deformity Correction (MID-C) System Executive Summary | 4/19/2023 |
| Prepopik for oral solution (sodium picosulfate/magnesium oxide/anhydrous citric acid) | Prepopik for oral solution (sodium picosulfate/magnesium oxide/anhydrous citric acid) Executive Summary | 4/19/2023 |
| Procysbi (cysteamine bitartrate) | Procysbi (cysteamine bitartrate) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| PulseRider Aneurysm Neck Reconstruction Device (none) | PulseRider Aneurysm Neck Reconstruction Device Safety Update Memorandum | 4/19/2023 |
| Qbrexza cloth (glycopyrronium) | Qbrexza cloth (glycopyrronium) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Seysara (sarecycline) | Seysara (sarecycline) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Sovaldi (sofosbuvir) | Sovaldi (sofosbuvir) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| The Tether - Vertebral Body Tethering System (none) | The Tether - Vertebral Body Tethering System Executive Summary | 4/19/2023 |
| Twyneo cream (tretinoin/benzoyl peroxide) | Twyneo cream (tretinoin/benzoyl peroxide) Safety Update Memorandum | 4/19/2023 |
| Winlevi cream (clascoterone) | Winlevi cream (clascoterone) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Xeomin injection (incobotulinumtoxinA) | Xeomin injection (incobotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Zovirax injection (acyclovir) | Zovirax injection (acyclovir) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 |
| Dysport (abobotulinumtoxinA) | Dysport (abobotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 6/19/2023 |
| Annovera (segesterone acetate/ethinyl estradiol ) | Annovera (segesterone acetate/ethinyl estradiol ) Safety Update Memorandum | 10/26/2023 |
| Aptensio XR (methylphenidate hydrochloride) | Aptensio XR (methylphenidate hydrochloride) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) | Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) Safety Update Memorandum | 10/26/2023 |
| Contegra (none) | Contegra Pediatric Executive Summary | 10/26/2023 |
| Dificid (fidaxomicin) | Dificid (fidaxomicin) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Enterra Gastric Electrical Stimulator (none) | Enterra Gastric Electrical Stimulator Executive Summary | 10/26/2023 |
| Epclusa (sofosbuvir/velpatasvir) | Epclusa (sofosbuvir/velpatasvir) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Epclusa oral pellets (sofosbuvir/velpatasvir) | Epclusa oral pellets (sofosbuvir/velpatasvir) Safety Update Memorandum | 10/26/2023 |
| Flector Topical System (diclofenac epolamine) | Flector Topical System Executive Summary | 10/26/2023 |
| Flourish Pediatric Esophageal Atresia Device (none) | Flourish Pediatric Esophageal Atresia Device Executive Summary | 10/26/2023 |
| Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) | Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) Safety Update Memorandum | 10/26/2023 |
| Jevtana (cabazitaxel) | Jevtana (cabazitaxel) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Nucala (mepolizumab) | Nucala (mepolizumab) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) | ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Executive Summary | 10/26/2023 |
| Otiprio (ciprofloxacin) | Otiprio (ciprofloxacin) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Phexxi vaginal gel (lactic acid/citric acid/potassium bitartrate) | Phexxi vaginal gel (lactic acid/citric acid/potassium bitartrate) Executive Summary | 10/26/2023 |
| Pleximmune (none) | Pleximmune (none) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Promacta (eltrombopag) | Promacta (eltrombopag) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| PulseRider Aneurysm Neck Reconstruction Device (none) | PulseRider Aneurysm Neck Reconstruction Device Executive Summary | 10/26/2023 |
| Saxenda injection (liraglutide) | Saxenda injection (liraglutide) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Sonalleve MR-HIFU (None) | Sonalleve MR-HIFU Executive Summary | 10/26/2023 |
| Sorilux (calcipotriene) | Sorilux (calcipotriene) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Tivicay PD tablets for oral suspension (dolutegravir) | Tivicay PD tablets for oral suspension (dolutegravir) Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Tivicay tablets (dolutegravir) | Tivicay tablets (dolutegravir) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) | VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) Safety Update Memorandum | 10/26/2023 |
| Victoza (liraglutide) | Victoza (liraglutide) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Vimpat (lacosamide) | Vimpat (lacosamide) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Yondelis injection (trabectedin) | Yondelis injection (trabectedin) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Zerviate (cetirizine) | Zerviate (cetirizine) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 |
| Aczone Gel (dapsone) | Aczone Gel (dapsone) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Adhansia XR (methylphenidate hydrochloride) | Adhansia XR (methylphenidate hydrochloride) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Aklief (trifarotene) | Aklief (trifarotene) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Ampicillin Injection (ampicillin) | Ampicillin Injection (ampicillin) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Amzeeq (minocycline) | Amzeeq (minocycline) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Arazlo (tazarotene) | Arazlo (tazarotene) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Asmanex HFA (mometasone furoate) | Asmanex HFA (mometasone furoate) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Baqsimi nasal powder (glucagon) | Baqsimi nasal powder (glucagon) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Ciloxan ophthalmic solution (ciprofloxacin) | Ciloxan ophthalmic solution (ciprofloxacin) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Conjupri (levamlodipine) | Conjupri (levamlodipine) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Doptelet tablet (avatrombopag) | Doptelet tablet (avatrombopag) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Dulera Inhalation Aerosol (formoterol fumarate/mometasone furoate) | Dulera Inhalation Aerosol Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Dutrebis (lamivudine/raltegravir) | Dutrebis (lamivudine/raltegravir) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Enstilar Foam (calcipotriene/betamethasone dipropionate) | Enstilar Foam (calcipotriene/betamethasone dipropionate) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Gvoke (glucagon) | Gvoke (glucagon) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Jublia topical solution (efinaconazole) | Jublia topical solution (efinaconazole) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Nuvessa (metronidazole) | Nuvessa (metronidazole) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Prezcobix tablets (darunavir/cobicistat) | Prezcobix tablets (darunavir/cobicistat)Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Primatene Mist (epinephrine) | Primatene Mist (epinephrine) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Quzyttir (cetirizine hydrochloride) | Quzyttir (cetirizine hydrochloride) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Sivextro tablet (tedizolid phosphate) | Sivextro tablet (tedizolid phosphate) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Spy Agent Green (Indocyanine green) | Spy Agent Green (Indocyanine green) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Symtuza tablets (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) | Symtuza tablets (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Taclonex (calcipotriene/betamethasone dipropionate) | Taclonex (calcipotriene/betamethasone dipropionate) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Taltz injection (ixekizumab) | Taltz injection (ixekizumab) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Truvada (emtricitabine/tenofovir disoproxil fumarate) | Truvada (emtricitabine/tenofovir disoproxil fumarate) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Vectical ointment (calcitriol) | Vectical ointment (calcitriol) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| VESIcare LS oral suspension (solifenacin succinate) | VESIcare LS oral suspension (solifenacin succinate) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Welchol (colesevelam hydrochloride) | Welchol (colesevelam hydrochloride) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Welchol Chewable Bar (colesevelam HCl) | Welchol Chewable Bar (colesevelam HCl) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
| Xtoro (finafloxacin) | Xtoro (finafloxacin) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
