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  1. Pediatric Advisory Committee

Pediatric Advisory Recommendations and Updates

The Pediatric Advisory Committee (PAC) advises and makes recommendations to the FDA about matters involving pediatrics. One of the PAC’s responsibilities is to review, evaluate, and make recommendations on adverse event reports of post market pediatric safety data for certain medical products. The safety reviews enable the FDA to identify safety concerns in children that may not be possible to detect before the product is marketed. The PAC also advises on aspects of Humanitarian Device Exemptions (HDEs) for certain HDE devices that are approved in pediatric patients.

The spreadsheet below includes medical products that have been shared with the PAC as required by federal law, FDA’s safety review information and the PAC’s recommendations.

Product Name Safety Review Date Posted
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)
Arnuity  Ellipta Safety and Utilization Review
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 Memorandum
K 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

 

See the Best Pharmaceuticals for Children Act, Pediatric Research Equity Act and Pediatric Medical Device Safety and Improvement Act for more information.

Additional Resources

 

 

 
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