| | Number of Inquiries Received by FDA | Does the product have a REMS with ETASU Impacting Distribution? | For Products with REMS with ETASU Impacting Distribution: Date(s) of Safety Determination Letter(s) Issued (if applicable) |
Absorica (isotretinoin) | RANBAXY INC/SUN PHARMACEUTICAL INDUSTRIES INC | 5 | Yes | 12/9/2015 |
Abstral (fentanyl citrate) | GALENA BIOPHARMA | 1 | Yes |
|
Accutane (isotretinoin) | ROCHE PALO ALTO LLC | 2 | Yes | 6/23/2009 |
Adempas (riociguat) | BAYER HEALTHCARE PHARMACEUTICALS INC | 2 | Yes | 9/27/2016; 5/2/2017 |
Afinitor (everolimus) | NOVARTIS PHARMACEUTICALS CORP | 1 | No | N/A |
Amnesteem (isotretinoin) | MYLAN PHARMACEUTICALS INC | 3 | Yes |
|
Ampyra (dalfampridine) | ACORDA THERAPEUTICS INC | 4 | No | N/A |
Brilinta (ticagrelor) | ASTRAZENECA LP | 1 | No | N/A |
Claravis (isotretinoin) | TEVA PHARMACEUTICALS USA | 4 | Yes |
|
Clozaril (clozapine) | HERITAGE LIFE SCIENCES BARBADOS INC | 1 | Yes |
|
Cystadane (betaine hydrochloride) | ORPHAN EUROPE SARL | 1 | No | N/A |
Embeda (morphine sulfate; naltrexone hydrochloride) | ALPHARMA PHARMACEUTICALS LLC KING PHARMACEUTICALS | 1 | No | N/A |
Entereg (alvimopan) | CUBIST PHARMACEUTICALS INC | 5 | Yes |
|
Exjade (deferasirox) | NOVARTIS PHARMACEUTICALS CORP | 6 | No | N/A |
Fazaclo ODT (clozapine) | JAZZ PHARMACEUTICALS III INTERNATIONAL LTD | 1 | Yes |
|
Fentora (fentanyl citrate) | CEPHALON INC | 1 | Yes |
|
Ferriprox (deferiprone) | APOPHARMA INC | 1 | No | N/A |
Firazyr (icatibant acetate) | SHIRE ORPHAN THERAPIES INC | 2 | No | N/A |
Gattex Kit (teduglutide recombinant) | NPS PHARMACEUTICALS INC | 1 | No | N/A |
Gilotrif (afatinib dimaleate) | BOEHRINGER INGELHEIM | 1 | No | N/A |
H.P. Acthar Gel (corticotropin) | QUESTCOR PHARMACEUTICALS INC | 2 | No | N/A |
Hemabate (carboprost tromethamine) | PHARMACIA AND UPJOHN CO | 1 | No | N/A |
Juxtapid (lomitapide mesylate) | AEGERION PHARMACEUTICALS INC | 3 | Yes |
|
Korlym (mifepristone) | CORCEPT THERAPEUTICS INC | 1 | No | N/A |
Kuvan (sapropterin dihydrochloride) | BIOMARIN PHARMACEUTICAL INC | 3 | No | N/A |
Letairis (ambrisentan) | GILEAD SCIENCES INC | 10 | Yes | 9/1/2015; 7/5/2016 |
Methadone Hydrochloride (methadone hydrochloride) | ROXANE LABORATORIES INC | 1 | No | N/A |
Mifeprex (mifepristone) | DANCO LABORATORIES LLC | 1 | Yes |
|
Nexavar (sorafenib tosylate) | BAYER HEALTHCARE PHARMACEUTICALS INC | 2 | No | N/A |
Onsolis (fentanyl citrate) | MEDA PHARMACEUTICALS INC | 1 | Yes |
|
Opsumit (macitentan) | ACTELION PHARMACEUTICALS LTD | 8 | Yes | 7/5/2016; 12/8/2016; 4/23/2018 |
Orfadin (nitisinone) | SWEDISH ORPHAN BIOVITRUM AB PUBL | 2 | No | N/A |
Pomalyst (pomalidomide) | CELGENE CORP | 8 | Yes |
|
Promacta (eltrombopag olamine) | GLAXOSMITHKLINE | 2 | Yes |
|
Promacta (eltrombopag olamine) | GLAXOSMITHKLINE | 1 | No | N/A |
Qsymia (phentermine hydrochloride; topiramate) | VIVUS INC | 8 | Yes | 8/13/2015 |
Ravicti (glycerol phenylbutyrate) | HYPERION THERAPEUTICS INC | 1 | No | N/A |
Revlimid (lenalidomide) | CELGENE CORP | 13 | Yes | 7/31/2012; 5/19/2014; 2/22/2017; 8/15/2017 |
Sabril (vigabatrin) for solution | LUNDBECK LLC / LUNDBECK PHARMACEUTICALS LLC | 3 | Yes |
|
Sabril (vigabatrin) tablet | LUNDBECK LLC / LUNDBECK PHARMACEUTICALS LLC | 4 | Yes |
|
Subsys (fentanyl) | INSYS THERAPEUTICS INC | 2 | Yes |
|
Tasigna (nilotinib hydrochloride monohydrate) | NOVARTIS PHARMACEUTICALS CORP | 3 | No | N/A |
Tecfidera (dimethyl fumarate) | BIOGEN IDEC INC | 1 | No | N/A |
Thalomid (thalidomide) | CELGENE CORP | 10 | Yes | 12/11/2007; 1/17/2008 |
Tikosyn (dofetilide) | PFIZER PHARMACEUTICALS PRODUCTION CORP LTD | 4 | Yes |
|
Tracleer (bosentan) | ACTELION PHARMACEUTICALS LTD | 14 | Yes | 7/31/2013; 9/1/2015; 9/1/2015; 10/16/2015; 1/29/2016 |
Truvada (emtricitabine; tenofovir disoproxil fumarate) | GILEAD SCIENCES INC | 1 | No | N/A |
Tykerb (lapatinib ditosylate) | SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE | 1 | No | N/A |
Veletri (epoprostenol sodium) | ACTELION PHARMACEUTICALS LTD | 1 | No | N/A |
Xenazine (tetrabenazine) | VALEANT INTERNATIONAL BERMUDA/VALEANT PHARMACEUTICALS NORTH AMERICA LLC | 4 | No | N/A |
Zavesca (miglustat) | ACTELION PHARMACEUTICALS LTD | 3 | No | N/A |
Zortress (everolimus) | NOVARTIS PHARMACEUTICALS CORP | 1 | No | N/A |