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  1. Pediatric Advisory Committee

Web-Posted Pediatric Safety Reviews

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Product Name Safety Review Date Posted Comment
Aczone (dapsone) gel, 7.5% Aczone Safety Review 03/28/2019 Docket is closed
Adynovate Adynovate Safety Review 03/28/2019 Docket is closed
AirDuo RespiClick (fluticasone propionate and salmeterol xinafoate)
ArmonAir RespiClick (fluticasone propionate)
AirDuo Respiclick and ArmonAir Respiclick Safety Review 03/28/2019 Docket is closed
Avelox (moxifloxacin, tablets and injection) Avelox Safety Review 03/28/2019 Docket is closed
Caldolor (ibuprofen) IV injection Caldolor Safety Review 03/28/2019 Docket is closed
Cubicin® and Cubicin® RF (daptomycin for injection) Cubicin Safety Review 03/28/2019 Docket is closed
Dexilant, Dexilant SoluTab (dexlansoprazole) Dexilant Safety Review 03/28/2019 Docket is closed
Epicel (cultured epidermal autografts) Epicel 2019 Executive Summary 03/28/2019 Docket is closed
Eucrisa (crisaborole) ointment, 2% Eucrisa Safety Review 03/28/2019 Docket is closed
Flourish™ Pediatric Esophageal Atresia Device Flourish 2019 Executive Summary 03/28/2019 Docket is closed
IXINITY [Coagulation Factor IX (Recombinant)] IXINITY Safety Review 03/28/2019 Docket is closed
Liletta (levonorgestrel-releasing intrauterine system) Liletta Safety Review 03/28/2019 Docket is closed
Liposorber® LA-15 System Liposorber 2019 Executive Summary 03/28/2019 Docket is closed
Lyrica (pregabalin) Lyrica Safety Review 03/28/2019 Docket is closed
Medtronic Activa Neurostimulator for Dystonia Treatment Medtronic Activa 2019 Executive Summary 03/28/2019 Docket is closed
Narcan (naloxone) nasal spray Narcan Safety Review 03/28/2019 Docket is closed
Ofirmev (acetaminophen) injection Ofirmev Safety Review 03/28/2019 Docket is closed
Selzentry (maraviroc) Selzentry Safety Review 03/28/2019 Docket is closed
Spiriva Respimat (tiotropium bromide) Spiriva Safety Review 03/28/2019 Docket is closed
Symbicort (budesonide/ formoterol fumarate dihydrate) Symbicort Safety Review 03/28/2019 Docket is closed
Tarceva™ (erlotinib) Tarceva Safety Review 03/28/2019 Docket is closed
Velcade® (bortezomib) Velcade Safety Review 03/28/2019 Docket is closed
Lamictal (lamotrigine) Lamictal Safety Review 09/12/2018 Docket is closed
Entocort EC (budesonide) Entocort EC Safety Review 09/12/2018 Docket is closed
Epzicom (abacavir sulfate and lamivudine) and Ziagen (abacavir sulfate) Epzicom and Ziagen Safety Review 09/12/2018 Docket is closed
Kovanaze (tetracaine HCl and oxymetazoline HCl) Kovanaze Safety Review 09/12/2018 Docket is closed
Oraverse (phentolamine mesylate) Oraverse Safety Review 09/12/2018 Docket is closed
Pancreaze & Pertzye (pancrelipase) Pancreaze & Pertzye Safety Review 09/12/2018 Docket is closed
Renvela (sevelamer carbonate) Renvela Safety Review 09/12/2018 Docket is closed
Zomig Nasal Spray (zolmitriptan) Zomig Nasal Spray Safety Review 09/12/2018 Docket is closed
Bexsero (Meningococcal Group B Vaccine) Bexsero Safety Review 09/12/2018 Docket is closed
Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) Quadracel Safety Review 09/12/2018 Docket is closed
Contegra Pulmonary Valved Conduit (Humanitarian Device Exemption [HDE]) Contegra 2018 Executive Summary 09/12/2018 Docket is closed
Elana Surgical Kit (HDE) Elana Surgical Kit 2018 Executive Summary 09/12/2018 Docket is closed
Pleximmune™ in-vitro diagnostic test (HDE) Pleximmune™2018 Executive Summary 09/12/2018 Docket is closed
PulseRider Aneurysm Neck Reconstruction Device (HDE) PulseRider 2018 Executive Summary 09/12/2018 Docket is closed
Enterra Therapy System (HDE) Enterra 2018 Executive Summary 09/12/2018 Docket is closed
Adzenys XR and Dyanavel XR (amphetamine) Dyanavel Pediatric Safety Review 06/13/2018 Docket is closed
Anthim (obiltoxaximab) Anthim Pediatric Safety Review 06/13/2018 Docket is closed
Aptensio XR and Quillichew (methylphenidate hydrochloride) Aptensio XR and Quillichew ER Pediatric Safety Review 06/13/2018 Docket is closed
Cinqair (reslizumab) Cinqair Pediatric Safety Review 06/13/2018 Docket is closed
Cutivate (fluticasone propionate) Cutivate Pediatric Safety Review 06/13/2018 Docket is closed
Descovy (emtricitabine and tenofovir alafenamide) Descovy Pediatric Safety Review 06/13/2018 Docket is closed
Epivir (lamivudine) Epivir Pediatric Safety Review 06/13/2018 Docket is closed
Kaletra (lopinavir and ritonavir) Kaletra Pediatric Safety Review 06/13/2018 Docket is closed
Natroba (spinosad) Natroba Pediatric Safety Review 06/13/2018 Docket is closed
Noxafil (posaconazole) Noxafil Pediatric Safety Review 06/13/2018 Docket is closed
Oraltag (iohexol) Oraltag Pediatric Safety Review 06/13/2018 Docket is closed
Otovel Otic Solution (ciprofloxacin and fluocinolone acetonide) Ovotel Pediatric Safety Review 06/13/2018 Docket is closed
Prilosec (omeprazole) Prilosec Pediatric Safety Review 06/13/2018 Docket is closed
ProAir RespiClick (abuterol sulfate) ProAir Respiclick Pediatric Safety Review 06/13/2018 Docket is closed
Procysbi (cysteamine bitartrate) Procysbi Pediatric Safety Review 06/13/2018 Docket is closed
Teflaro Injection (ceftaroline fosamil) Teflaro Pediatric Safety Review 06/13/2018 Docket is closed
Tetracaine Hydrochloride Ophthalmic Solution (tetracaine hydrochloride) Tetracaine Pediatric Safety Review 06/13/2018 Docket is closed
Xopenex HFA Inhalation Aerosol (levalbuterol) Xopenex Pediatric Safety Review 06/13/2018 Docket is closed
Atropine Sulfate Ophthalmic Solution, USP 1% Atropine Sulfate Ophthalmic Solution, USP 1% Pediatric Postmarketing Pharmacovigilance Review 03/05/2018 Docket is closed
Banzel (rufinamide)

Banzel (rufinamide) Pediatric Safety Review

Banzel (rufinamide) Pediatric Utilization Review

04/25/2018 Docket is closed
Medtronic Activa Dystonia Therapy Medtronic Activa Dystonia Therapy 2018 Executive Summary 04/25/2018 Docket is closed
Liposorber LA-15 System Liposorber LA-15 System 2018 Executive Summary 04/25/2018 Docket is closed
Emend (aprepitant) Capsule and Oral Suspension Emend (aprepitant) Capsule and Oral Suspension Pediatric Safety Review 03/05/2018 Docket is closed
Kapvay (clonidine extended-release) tablets Kapvay® (clonidine extended-release) tablets Pediatric Safety and Drug Utilization Review 03/05/2018 Docket is closed
Tivicay (dolutegravir) Tivicay (dolutegravir) Pediatric Safety Review 03/05/2018 Docket is closed
Gadavist (gadobutrol), Eovist or Primovist (gadoxetate disodium) Gadavist (gadobutrol) Eovist or Primovist (gadoxetate disodium) Pediatric Safety Review 03/05/2018 Docket is closed
Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) oral tablets Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) oral tablets Pediatric Safety Review 03/05/2018 Docket is closed
Saphris (asenapine) Saphris (asenapine) Pediatric Safety Review 03/05/2018 Docket is closed
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 Docket is closed
Nucala (mepolizumab) Nucala (mepolizumab) Pediatric Safety Review 03/05/2018 Docket is closed
Trumenba Meningococcal Group B Vaccine Trumenba Pediatric Pediatric Safety Review 03/05/2018 Docket is closed
Epicel (cultured epidermal autografts) Epicel (cultured epidermal autografts) Executive Summary, Pediatric Safety Update 03/05/2018 Docket is closed
Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) Gardasil 9 Pediatric Safety and Utilization Review 03/05/2018 Docket is closed
Flourish Pediatric Esophageal Atresia Device Flourish 2018 Executive Summary 03/05/2018 Docket is closed
Dymista (azelastine hydrochloride fluticasone propionate) Dymista (azelastine hydrochloride fluticasone propionate) Pediatric Safety Review 01/07/2018 Docket is closed
Edurant (rilpivirine) Complera and Odefsey Edurant (rilpivirine) Complera and Odefsey Pediatric Safety Review 01/07/2018 Docket is closed
Merrem IV (meropenem) Merrem IV (meropenem) Pediatric Safety Review 01/07/2018 Docket is closed
Naftin (nafifine hydrochloride) Naftin (nafifine hydrochloride) Pediatric Safety and Drug Utilization Review 01/07/2018 Docket is closed
OTIPRO (ciprofloxacin otic suspension) OTIPRO (ciprofloxacin otic suspension) Pediatric Safety Review 01/07/2018 Docket is closed
PAZEO (olopatadine hydrochloride ophthalmic solution) PAZEO (olopatadine hydrochloride ophthalmic solution) Pediatric Safety Review 01/07/2018 Docket is closed
QNASL beclomethasone dipropionate) nasal aerosol QNASL beclomethasone dipropionate) nasal aerosol Safety Review 01/07/2018 Docket is closed
Treximet (naproxen sodium sumatriptan succinate) Treximet (naproxen sodium sumatriptan succinate) Safety Review 01/07/2018 Docket is closed
Valcyte (valganciclovir) Valcyte (valganciclovir) Safety Review 01/07/2018 Docket is closed
Aleve PM® (naproxen sodium 220 mg and diphenhydramine hydrochloride 25 mg) Aleve PM® Safety and Utilization Review 02/03/2017 Docket is closed
ORALAIR (Sweet Vernal, Orchard Perennial rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for sublingual Use ORALAIR Safety and Utilization Review

FDA Drug Utilization Information on GRASTEK and ORALAIR
08/04/2017 Docket is closed
GRASTEK® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use GRASTEK Safety and Utilization Review

FDA Drug Utilization Information on GRASTEK and ORALAIR
08/04/2017 Docket is closed
Aloxi (palonosetron hydrochloride) Aloxi Safety and Utilization Review 08/04/2017 Docket is closed
Arnuity Ellipta (fluticasone furoate) Arnuity  Ellipta Safety and Utilization Review 08/04/2017 Docket is closed
Asmanex HFA  and Asmanex  Twisthaler (mometasone furoate inhalation) Asmanex HFA and Asmanex Twisthaler Safety and Utilization Review 08/04/2017 Docket is closed
Cymbalta (duloxetine) Cymbalta Safety and Utilization Review 08/04/2017 Docket is closed
Emsam (selegiline transdermal system) Emsam Safety and Utilization Review 08/04/2017 Docket is closed
Latisse® (bimatoprost ophthalmic solution) 0.03% Latisse® Safety and Utilization Review 08/04/2017 Docket is closed
Namenda and Namenda XR extended-release (memantine hydrochloride) Namenda and Namenda XR Safety and Utilization Review 08/04/2017 Docket is closed
Reyataz® (atazanavir) Reyataz® Safety and Utilization Review 08/04/2017 Docket is closed
Taclonex (betamethasone dipropionate/calcipotriene hydrate) 0.064%/0.005% Taclonex Safety and Utilization Review 08/04/2017 Docket is closed
Priftin® (rifapentine) Priftin® Safety and Utilization Review 08/04/2017 Docket is closed
Zetonna (ciclesonide) Zetonna (ciclesonide) Safety and Utilization Review 08/04/2017 Docket is closed
Astepro (azelastine hydrochloride) Astepro Safety and Utilization Review 02/03/2017 Docket is closed
Jetrea® (ocriplasmin) Intravitreal Injection Jetrea® Safety and Utilization Review 02/03/2017 Docket is closed
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets, for oral use) Quartette Safety and Utilization Review 02/03/2017 Docket is closed
Spectazole (econazole nitrate) cream, 1%
Ecoza (econazole nitrate) topical foam, 1%
Spectazole/Ecoza Safety and Utilization Review 02/03/2017 Docket is closed
Truvada® (emtricitabine and tenofovir disoproxil fumarate) Truvada® Safety and Utilization Review 02/03/2017 Docket is closed
Xerese® (5% acyclovir and 1% hydrocortisone cream) Xerese® Safety and Utilization Review 02/03/2017 Docket is closed
Baraclude (entecavir) Baraclude Safety and Utilization Review 09/12/2016 Docket is closed
Isentress (raltegravir potassium) Isentress Safety and Utilization Review 09/12/2016 Docket is closed
Lysteda (tranexamic acid) Lysteda Safety and Utilization Review 09/12/2016 Docket is closed
Salonpas Relief (methyl salicylate 10% and 1-menthol 3%P Patch) Salonpas Relief Safety and Utilization Review 09/12/2016 Docket is closed
Ativan injection (lorazepam injection) Ativan Pediatric Safety Review 09/19/2019 Docket is closed
Calcium gluconate injection (calcium gluconate) Calcium Gluconate Pediatric Safety Review 09/19/2019 Docket is closed
Cerebyx® (fosphenytoin sodium) Cerebyx® Pediatric Safety Review 09/19/2019 Docket is closed
Contegra Pulmonary Valved Conduit (Humanitarian Device Exemption [HDE]) Contegra 2019 Executive Summary 09/19/2019 Docket is closed
Dotarem (gadoterate meglumine) Dotarem Pediatric Safety Review 09/19/2019 Docket is closed
Elana Surgical Kit (HDE) Elana Surgical Kit 2019 Executive Summary 09/19/2019 Docket is closed
Enterra Therapy System (HDE) Enterra Therapy System 2019 Executive Summary 09/19/2019 Docket is closed
E-Z-HD (barium sulfate) Barium Sulfate Pediatric Safety Review 09/19/2019 Docket is closed
Fycompa oral tablets and suspension (perampanel) Fycompa Pediatric Safety Review 09/19/2019 Docket is closed
Gammaplex - Immune Globulin Intravenous (Human) 5% Liquid Gammaplex Safety and Utilization Review 09/19/2019 Docket is closed
Harvoni (ledipasvir and sofosbuvir) Harvoni Pediatric Safety Review 09/19/2019 Docket is closed
Isentress and Isentress HD (raltegravir)   Isentress and Isentress HD Pediatric Safety Review 09/19/2019 Docket is closed
Latuda (lurasidone hydrochloride) Latuda Pediatric Safety Review 09/19/2019 Docket is closed
Liquid E-Z-Paque (barium sulfate) Barium Sulfate Pediatric Safety Review 09/19/2019 Docket is closed
NUWIQ® (simoctocog alfa) NUWIQ® Safety and Utilization Review 09/19/2019 Docket is closed
Pleximmune™ in-vitro diagnostic test (HDE) Pleximmune™ 2019 Executive Summary 09/19/2019 Docket is closed
PulseRider Aneurysm Neck Reconstruction Device (HDE) PulseRider 2019 Executive Summary 09/19/2019 Docket is closed
Rapivab® (peramivir) Rapivab® Pediatric Safety Review 09/19/2019 Docket is closed
Readi-Cat 2, Readi-Cat 2 smoothies (barium sulfate) Barium Sulfate Pediatric Safety Review 09/19/2019 Docket is closed
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 Docket is closed
Simponi (golimumab SC), Simponi Aria (golimumab IV) Simponi Pediatric Safety Review 09/19/2019 Docket is closed
Sovaldi (sofosbuvir) Sovaldi Pediatric Safety Review 09/19/2019 Docket is closed
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) Stribild Pediatric Safety Review 09/19/2019 Docket is closed
TACHOSIL (Fibrin Sealant Patch) TACHOSIL Safety and Utilization Review 09/19/2019 Docket is closed
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 Docket is closed
Varibar pudding (barium sulfate) Barium Sulfate Pediatric Safety Review 09/19/2019 Docket is closed
Vigamox (moxifloxacin hydrochloride ophthalmic solution 0.5%) Vigamox Pediatric Safety Review 09/19/2019 Docket is closed
Visipaque injection (iodixanol)   Visipaque Pediatric Safety Review 09/19/2019 Docket is closed
WILATE (von Willebrand Factor/ Coagulation Factor VIII Complex (Human)) WILATE Safety and Utilization Review 09/19/2019 Docket is closed
Zemplar (paricalcitol) Zemplar Pediatric Safety Review 09/19/2019 Docket is closed
Zymar® 0.3% (gatifloxacin ophthalmic solution) Zymar® Pediatric Safety Review 09/19/2019 Docket is closed