Web-Posted Pediatric Safety Reviews
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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 |