Web-Posted Pediatric Safety Reviews
Persons with disabilities having problems accessing any of the PDF files below may call 240-402-3838 for assistance.
| Product Name | Safety Review | Date Posted | Comment |
|---|---|---|---|
| Cialis (tadalafil) | Cialis Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | Docket is closed |
| Elana Surgical Kit (HDE) | Elana Surgical Kit Executive Summary | 09/03/2021 | Docket is closed |
| Emend (fosaprepitant dimeglumine) | Emend Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | Docket is closed |
| Enbrel (etanercept), Erelzi (etanercept-szzs), Eticovo (etanercept-ykro) | Enbrel Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | Docket is closed |
| Enterra Therapy System (HDE) | Enterra Therapy System Executive Summary | 09/03/2021 | Docket is closed |
| Fasenra (benralizumab) | Fasenra Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | Docket is closed |
| Intelence (etravirine) | Intelence Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | Docket is closed |
| Medtronic Contegra Pulmonary Valved Conduit (HDE) | Medtronic Contegra Pulmonary Valved Conduit Executive Summary | 09/03/2021 | Docket is closed |
| Pleximmune™ in-vitro diagnostic test (HDE) | Pleximmune Executive Summary | 09/03/2021 | Docket is closed |
| PulseRider Aneurysm Neck Reconstruction Device (HDE) | PulseRider Aneurysm Neck Reconstruction Device Executive Summary | 09/03/2021 | Docket is closed |
| RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) | Rotateq Safety and Utilization Review | 09/03/2021 | Docket is closed |
| 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 | Docket is closed |
| T.R.U.E. TEST (Thin-Layer Rapid Use Epicutaneous Patch Test) | T.R.U.E. TEST Safety and Utilization Review | 09/03/2021 | Docket is closed |
| Tekturna (aliskiren hemifumarate) | Tekturna Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | Docket is closed |
| Viread (tenofovir disoproxil fumarate) | Viread Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | Docket is closed |
| Xofluza (baloxavir marboxil) | Xofluza Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | Docket is closed |
| Aptiom (eslicarbazepine acetate) | Aptiom Pediatric Postmarketing Pharmacovigilance Review | 04/26/2021 | Docket is closed |
| Cotempla XR-ODT (methylphenidate extended release orally disintegrating tablets) | Cotempla Pediatric Postmarketing Pharmacovigilance Review | 04/26/2021 | Docket is closed |
| Pegasys (peginterferon alpha-2a) | Pegasys Pediatric Postmarketing Pharmacovigiliance Review | 04/26/2021 | Docket is closed |
| Vimovo (naproxen/esomeprazole magnesium) | Vimovo Pediatric Postmarketing Pharmacovigilance Review | 04/26/2021 | Docket is closed |
| Cuvitru, Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution | Cuvitru Safety and Utilization Review | 04/26/2021 | Docket is closed |
| Epicel (cultured epidermal autografts) | Epicel Safety Update | 04/26/2021 | Docket is closed |
| JIVI (Antihemophilic Factor (Recombinant), PEGylated-aucl) | JIVI Safety and Utilization Review | 04/26/2021 | Docket is closed |
| REBINYN (nonacog beta pegol (N9-GP)) | REBINYN Safety and Utilization Review | 04/26/2021 | Docket is closed |
| Medtronic Activa® Dystonia Therapy (HDE) | Medtronic Activa® Dystonia Therapy Executive Summary | 04/26/2021 | Docket is closed |
| Liposorber® LA-15 System | Liposorber® LA-15 System Executive Summary | 04/26/2021 | Docket is closed |
| Minimally Invasive Deformity Correction (MID-C) System | Minimally Invasive Deformity Correction (MID-C) System Executive Summary | 04/26/2021 | Docket is closed |
| The Tether™ – Vertebral Body Tethering System | The Tether™ – Vertebral Body Tethering System Executive Summary | 04/26/2021 | Docket is closed |
| Contegra Pulmonary Valved Conduit (HDE) | Contegra Pulmonary Valved Conduit Executive Summary | 09/01/2020 | Docket is closed |
| Enterra Therapy System (HDE) | Enterra Therapy System Executive Summary | 09/01/2020 | Docket is closed |
| PulseRider Aneurysm Neck Reconstruction Device (HDE) | PulseRider Aneurysm Neck Reconstruction Device Executive Summary | 09/01/2020 | Docket is closed |
| Flucelvax (influenza vaccine) | Flucelvax Safety and Utilization Review | 09/01/2020 | Docket is closed |
| Flucelvax Quadrivalent (influenza vaccine) | Flucelvax Quadrivalent Safety and Utilization Review | 09/01/2020 | Docket is closed |
| FluLaval (influenza vaccine) | FluLaval Safety and Utilization Review | 09/01/2020 | Docket is closed |
| FluLaval Quadrivalent (influenza vaccine) | FluLaval Quadrivalent Safety and Utilization Review | 09/01/2020 | Docket is closed |
| Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] | Hiberix Safety and Utilization Review | 09/01/2020 | Docket is closed |
| Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted | Influenza A (H5N1) Virus Monovalent Vaccine Safety and Utilization Review | 09/01/2020 | Docket is closed |
| Elana Surgical Kit (HDE) | Elana Surgical Kit Executive Summary | 09/01/2020 | Docket is closed |
| Pleximmune™ in-vitro diagnostic test (HDE) | Pleximmune™ in-vitro diagnostic test Executive Summary | 09/01/2020 | Docket is closed |
| Canasa (mesalamine suppositories for rectal use) | Canasa Pediatric Safety Review | 09/01/2020 | Docket is closed |
| Descovy® (emtricitabine and tenofovir alafenamide) | Descovy® Pediatric Safety Review | 09/01/2020 | Docket is closed |
| Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir | Genvoya® Pediatric Safety Review | 09/01/2020 | Docket is closed |
| Lumify (brimonidine tartrate) OTC | Lumify Pediatric Safety Review | 09/01/2020 | Docket is closed |
| Luzu (luliconazole) cream, 1% | Luzu Pediatric Safety Review | 09/01/2020 | Docket is closed |
| Sensipar (cinacalcet) | Sensipar Pediatric Safety Review | 09/01/2020 | Docket is closed |
| Triumeq (abacavir, dolutegravir, and lamivudine) | Triumeq Pediatric Safety Review | 09/01/2020 | Docket is closed |
| Xepi (ozenoxacin) | Xepi Pediatric Safety Review | 09/01/2020 | Docket is closed |
| Medtronic Activa® Dystonia Therapy (HDE) | Medtronic Activa® Dystonia Therapy 2020 Executive Summary | 07/13/2020 | Docket is closed |
| AFSTYLA (antihemophilic factor (recombinant), single chain) | AFSTYLA Safety and Utilization Review | 07/13/2020 | Docket is closed |
| Butrans (buprenorphine transdermal system) | Butrans Pediatric Safety and Utilization Review | 07/13/2020 | Docket is closed |
| DraxImage DTPA (technetium TC-99m pentetate kit) injection and inhalation | DraxImage DTPA Pediatric Safety Review | 07/13/2020 | Docket is closed |
| Dysport (AbobotulinumtoxinA) | Dysport Pediatric Safety Review | 07/13/2020 | Docket is closed |
| Epicel (cultured epidermal autografts) | Epicel 2020 Executive Summary | 07/13/2020 | Docket is closed |
| KOVALTRY (antihemophilic factor (recombinant)) | KOVALTRY Safety and Utilization Review | 07/13/2020 | Docket is closed |
| Liposorber® LA-15 System (HDE) | Liposorber® LA-15 System 2020 Executive Summary | 07/13/2020 | Docket is closed |
| Lumason (sulfur hexafluoride lipid-type A microspheres) injectable suspension | Lumason Pediatric Safety Review | 07/13/2020 | Docket is closed |
| Omidria (phenylephrine and ketorolac intraocular solution) | Omidria Pediatric Safety Review | 07/13/2020 | Docket is closed |
| Stelara (ustekinumab) injection | Stelara Pediatric Safety Review | 07/13/2020 | Docket is closed |
| 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 | Docket is closed |
| 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) | 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 |