The REMS Directory is a comprehensive listing of factual information about Risk Evaluation and Mitigation Strategy (REMS) programs with relevant information about the product for which the REMS was required. Products for which REMS have been required and approved by the FDA appear in the Approved REMS listing. Products approved before the provisions of the Food and Drug Administration Amendments Act (FDAAA) took effect that have been deemed to have a REMS appear in the Deemed REMS listing.

We have provided access to comprehensive information on a select number of products below (). For additional information on other products listed, please contact us.

Approved REMS

Actemra

Generic Name: tocilzumabStatus: Approved
NDA/BLA Holder: Hoffman LaRocheNDA/BLA Number: BLA 125276/0NDA/BLA Approval: 1/8/2010

Actoplus Met

Generic Name: pioglitazone hydrochloride and metformin hydrochlorideStatus: Approved
NDA/BLA Holder: TakedaNDA/BLA Number: NDA 21-842/S-009NDA/BLA Approval: 8/29/2005

Actoplus Met XR

Generic Name: pioglitazone hydrochloride and metformin hydrochloride extended-releaseStatus: Approved
NDA/BLA Holder: TakedaNDA/BLA Number: NDA 22-024NDA/BLA Approval: 5/12/2009

Actos

Generic Name: pioglitazone hydrochlorideStatus: Approved
NDA/BLA Holder: TakedaNDA/BLA Number: NDA 21-073/S-037NDA/BLA Approval: 7/15/1999

Advair Diskus

Generic Name: fluticasone propionate and salmeterol xinafoateStatus: Approved
NDA/BLA Holder: GlaxoSmithKlineNDA/BLA Number: NDA 21-077/S-029NDA/BLA Approval: 8/24/2000

Advair HFA

Generic Name: fluticasone propionate and salmeterol xinafoateStatus: Approved
NDA/BLA Holder: GlaxoSmithKlineNDA/BLA Number: NDA 21-254/S-007NDA/BLA Approval: 6/8/2006

Ampyra

Generic Name: dalfampridineStatus: Approved
NDA/BLA Holder: Acorda TherapeuticsNDA/BLA Number: NDA 22-250NDA/BLA Approval: 1/22/2010

Androgel

Generic Name: testosteroneStatus: Approved
NDA/BLA Holder: Unimed PharmaceuticalsNDA/BLA Number: NDA 21-015/S-022NDA/BLA Approval: 2/28/2000

Aplenzin Extended-Release Tablets

Generic Name: bupropion hydrobromideStatus: Approved
NDA/BLA Holder: Biovail LabsNDA/BLA Number: NDA 22-108NDA/BLA Approval: 4/23/2008

Aranesp

Generic Name: darbepoetin alfaStatus: Approved
NDA/BLA Holder: AmgenNDA/BLA Number: BLA 103951/5197NDA/BLA Approval: 9/17/2001

Avandamet Tablets

Generic Name: rosiglitazone maleate and metformin hydrochlorideStatus: Approved
NDA/BLA Holder: SB Pharmco NDA/BLA Number: NDA 21-410/S-025NDA/BLA Approval: 10/10/2002

Avandaryl Tablets

Generic Name: rosiglitazone maleate and glimepirideStatus: Approved
NDA/BLA Holder: SB PharmcoNDA/BLA Number: NDA 21-700/S-008NDA/BLA Approval: 11/23/2005

Avelox Tablets and I.V. Solution

Generic Name: moxifloxacinStatus: Approved
NDA/BLA Holder: BayerNDA/BLA Number: NDA 21-085/S-042, NDA 21-277/S-036 NDA/BLA Approval: 12/10/1999, 11/30/2001

Banzel Tablets

Generic Name: rufinamideStatus: Approved
NDA/BLA Holder: Eisai Inc.NDA/BLA Number: NDA 21-911NDA/BLA Approval: 11/14/2008

Botox/Botox Cosmetic

Generic Name: onabotulinumtoxinAStatus: Approved
NDA/BLA Holder: AllerganNDA/BLA Number: BLA 103000/5210, 5209NDA/BLA Approval: 12/9/1991

Butrans

Generic Name: buprenorphine Transdermal SystemStatus: Approved
NDA/BLA Holder: Purdue PharmaNDA/BLA Number: NDA 21-306/S-001NDA/BLA Approval: 06/30/2010

Byetta

Generic Name: exanatideStatus: Approved
NDA/BLA Holder: AmylinNDA/BLA Number: NDA 21-773/S-009, S-011, S-017, S-018, S-022, S-025, NDA 21-919NDA/BLA Approval: 4/28/2005, 10/30/2009

Cambia

Generic Name: diclofenac potassiumStatus: Approved
NDA/BLA Holder: KowaNDA/BLA Number: NDA 22-165NDA/BLA Approval: 6/17/2009

Celontin

Generic Name: methsuximideStatus: Approved
NDA/BLA Holder: Parke-DavisNDA/BLA Number: NDA 10-596NDA/BLA Approval: 02/08/1957

Chantix

Generic Name: vareniclineStatus: Approved
NDA/BLA Holder: PfizerNDA/BLA Number: NDA 21-928/S-011NDA/BLA Approval: 5/10/2006

Cimzia Lyophilized Powder for Solution for Subcutaneous Injection

Generic Name: certolizumab pegolStatus: Approved
NDA/BLA Holder: UCBNDA/BLA Number: BLA 125160/0NDA/BLA Approval: 4/22/2008

Cipro Tablets, Oral Suspension, I.V. Solution, and Extended-Release Tablets

Generic Name: ciprofloxacinStatus: Approved
NDA/BLA Holder: BayerNDA/BLA Number: NDA 19-537/S-070, NDA 19-847/S-044, NDA 19-857/S-051, NDA 20-780/S-028, NDA 21-473/S-025 NDA/BLA Approval: 10/22/1987, 12/26/1990, 12/26/1990, 9/26/1997, 12/13/2002

Colcrys

Generic Name: colchicineStatus: Approved
NDA/BLA Holder: Mutual PharmaNDA/BLA Number: NDA 22-351NDA/BLA Approval: 7/30/2009

Colcrys

Generic Name: colchicineStatus: Approved
NDA/BLA Holder: AR Holding Co, Inc.NDA/BLA Number: NDA 22-352NDA/BLA Approval: 7/29/2009

Colcrys

Generic Name: colchicineStatus: Approved
NDA/BLA Holder: Mutual PharmaNDA/BLA Number: NDA 22-353NDA/BLA Approval: 10/16/2009

Copegus

Generic Name: ribavirinStatus: Approved
NDA/BLA Holder: RocheNDA/BLA Number: NDA 21-511NDA/BLA Approval: 12/2/2002

Creon Delayed-Release Capsules

Generic Name: pancrelipase Status: Approved
NDA/BLA Holder: SolvayNDA/BLA Number: NDA 20-725NDA/BLA Approval: 4/30/2009

Darvon, Darvon-N, Darvocet-N

Generic Name: propoxyphene tabletsStatus: Approved
NDA/BLA Holder: XanodyneNDA/BLA Number: NDA 10-997/S-051, S-052; NDA 16-062/S-041, S-042; NDA 17-122/S-061, S-062NDA/BLA Approval: 8/16/1957, 9/9/197, 12/19/1972

Duetact

Generic Name: pioglitazone hydrochloride and glimepirideStatus: Approved
NDA/BLA Holder: TakedaNDA/BLA Number: NDA 21-925/S-007NDA/BLA Approval: 7/28/2006

Dulera

Generic Name: mometasone furoate and formoterol fumarateStatus: Approved
NDA/BLA Holder: ScheringNDA/BLA Number: NDA 22-518NDA/BLA Approval: 06/22/2010

Dysport Injection

Generic Name: abobotulinumtoxin AStatus: Approved
NDA/BLA Holder: IpsenNDA/BLA Number: BLA 125274/0, 125274/1NDA/BLA Approval: 4/30/2009

Edluar Sublingual Tablets

Generic Name: zolpidem tartrateStatus: Approved
NDA/BLA Holder: Orexo ABNDA/BLA Number: NDA 21-997NDA/BLA Approval: 3/13/2009

Effient

Generic Name: prasugrelStatus: Approved
NDA/BLA Holder: Eli Lilly and CompanyNDA/BLA Number: NDA 22-307NDA/BLA Approval: 7/10/2009

Embeda

Generic Name: morphine sulfate and naltrexone hydrochlorideStatus: Approved
NDA/BLA Holder: King PharmaceuticalsNDA/BLA Number: NDA 22-321NDA/BLA Approval: 8/13/2009

Enbrel for Subcutaneous Injection

Generic Name: etanercept Status: Approved
NDA/BLA Holder: Immunex / AmgenNDA/BLA Number: BLA 103795/5359NDA/BLA Approval: 11/2/1998

Entereg Capsules

Generic Name: alvimopanStatus: Approved
NDA/BLA Holder: AdolorNDA/BLA Number: NDA 21-775NDA/BLA Approval: 5/20/2008

Epogen/Procrit

Generic Name: epoetin alfaStatus: Approved
NDA/BLA Holder: AmgenNDA/BLA Number: BLA 103234/5199NDA/BLA Approval: 6/1/1989

Epzicom Tablets

Generic Name: abacavir sulfate and lamivudine Status: Approved
NDA/BLA Holder: GlaxoSmithKlineNDA/BLA Number: NDA 21-652/S-008NDA/BLA Approval: 8/2/2004

Equetro

Generic Name: carbamazepineStatus: Approved
NDA/BLA Holder: Validus PharmaceuticalsNDA/BLA Number: NDA 21-710NDA/BLA Approval: 12/10/2004

Exalgo

Generic Name: Hydromorphone Hydrochloride Extended Release TabletsStatus: Approved
NDA/BLA Holder: Mallinckrodt IncNDA/BLA Number: NDA 21-217NDA/BLA Approval: 03/01/2010

Extavia

Generic Name: interferon beta-1 bStatus: Approved
NDA/BLA Holder: NovartisNDA/BLA Number: BLA 125290/0NDA/BLA Approval: 8/14/2009

Factive Tablets

Generic Name: gemifloxacin Status: Approved
NDA/BLA Holder: OscientNDA/BLA Number: NDA 21-158/S-014NDA/BLA Approval: 4/4/2003

Forteo

Generic Name: Teriparatide [rDNA origin]Status: Approved
NDA/BLA Holder: Eli Lilly and CompanyNDA/BLA Number: NDA 21-318NDA/BLA Approval: 11/26/2002

Gabitril

Generic Name: tiagabine hydrochlorideStatus: Approved
NDA/BLA Holder: CephalonNDA/BLA Number: NDA 20-646NDA/BLA Approval: 09/30/1997

Gilenya

Generic Name: fingolimodStatus: Approved
NDA/BLA Holder: Novartis NDA/BLA Number: NDA 22-527NDA/BLA Approval: 09/21/2010

H.P. Acthar Gel

Generic Name: repository corticotropinStatus: Approved
NDA/BLA Holder: Questcor PharmaceuticalsNDA/BLA Number: NDA 22-432NDA/BLA Approval: 10/15/2010

HalfLytely Bisacodyl Bowel Prep Kit

Generic Name: bisacodyl, polyethylene glycol 3500, KCl, NaHCO3, NaClStatus: Approved
NDA/BLA Holder: BraintreeNDA/BLA Number: NDA 21-551/S-013NDA/BLA Approval: 05/10/2004

Humira

Generic Name: adalimumabStatus: Approved
NDA/BLA Holder: AbbottNDA/BLA Number: BLA 125057NDA/BLA Approval: 12/31/2002

Infergen

Generic Name: interferon alfacon-1Status: Approved
NDA/BLA Holder: IntermuneNDA/BLA Number: BLA 103663/5074NDA/BLA Approval: 10/6/1997

Intron A

Generic Name: interferon alfa-2aStatus: Approved
NDA/BLA Holder: ScheringNDA/BLA Number: BLA 103132/5108NDA/BLA Approval: 6/1/1986

Invirase

Generic Name: saquinavir mesylateStatus: Approved
NDA/BLA Holder: Hoffmann-LaRocheNDA/BLA Number: NDA 20-628NDA/BLA Approval: 12/06/2010

Janumet

Generic Name: sitagliptin/metforminStatus: Approved
NDA/BLA Holder: MerckNDA/BLA Number: NDA 22-044NDA/BLA Approval: 03/30/2007

Januvia

Generic Name: sitagliptin phosphateStatus: Approved
NDA/BLA Holder: MerckNDA/BLA Number: NDA 21-995NDA/BLA Approval: 10/16/2006

Kalbitor

Generic Name: ecallentideStatus: Approved
NDA/BLA Holder: Dyax CorporationNDA/BLA Number: BLA 125277NDA/BLA Approval: 11/27/2009

Kaletra Oral Solution

Generic Name: lopinavir and ritonavir Status: Approved
NDA/BLA Holder: AbbottNDA/BLA Number: NDA 21-251/S-023, NDA 21-906/S-014NDA/BLA Approval: 11/15/2000, 10/28/2005

Keppra, Keppra XR Tablets, Extended-Release Tablets, Oral Solution, and Injection

Generic Name: levetiracetamStatus: Approved
NDA/BLA Holder: UCBNDA/BLA Number: NDA 21-035/S-078, S-080, NDA 21-505/S-021, S-024NDA/BLA Approval: 11/30/1999, 7/15/2003

Klonopin

Generic Name: clonazepamStatus: Approved
NDA/BLA Holder: RocheNDA/BLA Number: NDA 20-813NDA/BLA Approval: 12/23/1997

Krystexxa

Generic Name: pegloticaseStatus: Approved
NDA/BLA Holder: SavientNDA/BLA Number: BLA 125293NDA/BLA Approval: 09/14/2010

Lamictal Extended-Release Tablets

Generic Name: lamotrigineStatus: Approved
NDA/BLA Holder: GlaxoSmithKlineNDA/BLA Number: NDA 22-115/S-001, S-005NDA/BLA Approval: 5/29/2009

Lamictal Tablets and Chewable Dispersible Tablets

Generic Name: lamotrigineStatus: Approved
NDA/BLA Holder: GlaxoSmithKlineNDA/BLA Number: NDA 20-241/S-037, S-038, NDA 20-764/S-030, 031NDA/BLA Approval: 12/27/1994, 8/24/1998

Lamictal XR

Generic Name: lamotrigineStatus: Approved
NDA/BLA Holder: GSKNDA/BLA Number: NDA 22-509/S-001NDA/BLA Approval: 5/29/2009

Lariam

Generic Name: mefloquine hydrochlorideStatus: Discontinued
NDA/BLA Holder: RocheNDA/BLA Number: NDA 19-591/S-026, 19-591/S-028NDA/BLA Approval: 5/2/1989

Letairis

Generic Name: ambrisentanStatus: Approved
NDA/BLA Holder: Gilead Sciences, Inc.NDA/BLA Number: NDA 22-081NDA/BLA Approval: 6/15/2007

Levaquin Tablets, Injection, and Oral Solution

Generic Name: levofloxacinStatus: Approved
NDA/BLA Holder: Ortho McNeil JanssenNDA/BLA Number: NDA 20-634/ S-053, NDA 20-635/ S-058, NDA 21-721/ S-021NDA/BLA Approval: 12/20/1996, 12/20/1996, 10/21/2004

Lotronex

Generic Name: alosetronStatus: Approved
NDA/BLA Holder: Prometheus LabsNDA/BLA Number: NDA 21-107NDA/BLA Approval: 2/9/2000

Lumizyme

Generic Name: alglucosidase alfaStatus: Approved
NDA/BLA Holder: GenzymeNDA/BLA Number: BLA 125291NDA/BLA Approval: 05/24/2010

Lyrica Capsules

Generic Name: pregabalinStatus: Approved
NDA/BLA Holder: CP PharmsNDA/BLA Number: NDA 21-446/S-013, S-014NDA/BLA Approval: 12/30/2004

Meridia

Generic Name: sibutramine hydrochlorideStatus: Approved
NDA/BLA Holder: AbbottNDA/BLA Number: NDA 20-632NDA/BLA Approval: 11/22/1997

Metoclopramide

Generic Name: metoclopramide hydrochlorideStatus: Approved
NDA/BLA Holder: SilarxNDA/BLA Number: ANDA 73-680/S-018NDA/BLA Approval: 10/27/1992

Metoclopramide

Generic Name: metoclopramide hydrochlorideStatus: Approved
NDA/BLA Holder: Morton GroveNDA/BLA Number: ANDA 74-703/S-007NDA/BLA Approval: 10/31/1997

Metoclopramide

Generic Name: metoclopramide hydrochlorideStatus: Approved
NDA/BLA Holder: Pharmaceutical AssociatesNDA/BLA Number: ANDA 72-744/S-011NDA/BLA Approval: 5/28/1991

Metoclopramide

Generic Name: metoclopramide hydrochlorideStatus: Approved
NDA/BLA Holder: ANI PharmaceuticalsNDA/BLA Number: ANDA 71-402/S-008NDA/BLA Approval: 6/25/1993

Metozolv ODT

Generic Name: metoclopramide hydrochlorideStatus: Approved
NDA/BLA Holder: SalixNDA/BLA Number: NDA 22-246NDA/BLA Approval: 9/4/2009

Morphine Sulfate Oral Solution

Generic Name: morphine sulfateStatus: Approved
NDA/BLA Holder: RoxaneNDA/BLA Number: NDA 22-195/S-002NDA/BLA Approval: 3/17/2008

Multaq

Generic Name: dronedaroneStatus: Approved
NDA/BLA Holder: sanofi-aventisNDA/BLA Number: NDA 22-425NDA/BLA Approval: 7/1/2009

Myobloc

Generic Name: rimabotulinumtoxinBStatus: Approved
NDA/BLA Holder: ElanNDA/BLA Number: BLA 103846/5120NDA/BLA Approval: 12/8/2000

Mysoline Tablets

Generic Name: primidoneStatus: Approved
NDA/BLA Holder: Valeant PharmaceuticalsNDA/BLA Number: NDA 9170/S-035NDA/BLA Approval: 03/8/1954

Neurontin

Generic Name: gabapentinStatus: Approved
NDA/BLA Holder: PfizerNDA/BLA Number: NDA 20-235NDA/BLA Approval: 12/30/1993

Noroxin Tablets

Generic Name: norfloxacin Status: Approved
NDA/BLA Holder: MerckNDA/BLA Number: NDA 19-384/S-054NDA/BLA Approval: 10/31/1986

Nplate for Subcutaneous Injection

Generic Name: romiplostim Status: Approved
NDA/BLA Holder: AmgenNDA/BLA Number: BLA 125268NDA/BLA Approval: 8/22/2008

Nuvigil

Generic Name: armodafinilStatus: Approved
NDA/BLA Holder: CephalonNDA/BLA Number: NDA 21-875NDA/BLA Approval: 06/15/2007

Oleptro

Generic Name: trazadone hydrochlorideStatus: Approved
NDA/BLA Holder: LabopharmNDA/BLA Number: NDA 22-411NDA/BLA Approval: 2/2/2010

Onsolis

Generic Name: fentanyl buccal soluble filmStatus: Approved
NDA/BLA Holder: BioDelivery Science International Inc.NDA/BLA Number: NDA 22-226NDA/BLA Approval: 7/16/2009

Osmoprep

Generic Name: sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrateStatus: Approved
NDA/BLA Holder: Salix PharmaceuticalsNDA/BLA Number: NDA 21-892/S-004NDA/BLA Approval: 3/16/2006

Oxycodone Hydrochloride (Brand Name Drug)

Generic Name: oxycodone hydrochlorideStatus: Approved
NDA/BLA Holder: Lehigh Valley TechnologiesNDA/BLA Number: NDA 200535NDA/BLA Approval: 10/20/2010

Oxycontin

Generic Name: oxycondone hydrochlorideStatus: Approved
NDA/BLA Holder: Purdue PharmaNDA/BLA Number: NDA 22-272NDA/BLA Approval: 4/5/2010

Pancreaze

Generic Name: pancrelipase (amylase, lipase, protease)Status: Drug Marketed, but w/o approved NDA
NDA/BLA Holder: Ortho McNeil JanssenNDA/BLA Number: NDA 22-523NDA/BLA Approval: N/A

Peganone

Generic Name: EthotoinStatus: Approved
NDA/BLA Holder: Lundbeck Inc.NDA/BLA Number: NDA 10-841NDA/BLA Approval: 04/22/1957

Pegasys

Generic Name: peginterferon alfa-2aStatus: Approved
NDA/BLA Holder: Hoffman-La RocheNDA/BLA Number: BLA 103964NDA/BLA Approval: 10/16/2002

PegIntron

Generic Name: peginterferon alfa-2bStatus: Approved
NDA/BLA Holder: ScheringNDA/BLA Number: BLA 103949/5171, 5174NDA/BLA Approval: 1/19/2001

PegIntron Rebetol Combopack Redipen Single-dose Delivery System and Rebetol Ribavirin

Generic Name: peginterferon alfa-2b, Status: Approved
NDA/BLA Holder: ScheringNDA/BLA Number: BLA 125196/0NDA/BLA Approval: 6/13/2008

Pennsaid

Generic Name: diclofenac sodiumStatus: Approved
NDA/BLA Holder: Nuvo ResearchNDA/BLA Number: NDA 20-947NDA/BLA Approval: 11/4/2009

Pradaxa

Generic Name: dabigatran etexilate mesylateStatus: Approved
NDA/BLA Holder: Boehringer IngelheimNDA/BLA Number: NDA 22-512NDA/BLA Approval: 10/19/2010

Prolia

Generic Name: denosumabStatus: Approved
NDA/BLA Holder: AmgenNDA/BLA Number: BLA 125320NDA/BLA Approval: 06/01/2010

Promacta Tablets

Generic Name: eltrombopag Status: Approved
NDA/BLA Holder: GlaxoSmithKlineNDA/BLA Number: NDA 22-291NDA/BLA Approval: 11/20/2008

Propylthiouracil

Generic Name: propylthiouracilStatus: Approved
NDA/BLA Holder: Dava PhamaceuticalsNDA/BLA Number: NDA 06-188NDA/BLA Approval: 07/28/1947

Proquin XR Extended-Release Tablets

Generic Name: ciprofloxacin Status: Approved
NDA/BLA Holder: Depomed IncNDA/BLA Number: NDA 21-744/S-012NDA/BLA Approval: 5/19/2005

Provigil

Generic Name: modafinilStatus: Approved
NDA/BLA Holder: CephalonNDA/BLA Number: NDA 20-717NDA/BLA Approval: 12/24/1998

Qualaquin

Generic Name: quinine sulfateStatus: Approved
NDA/BLA Holder: AR Holding Co Inc.NDA/BLA Number: NDA 21-799NDA/BLA Approval: 08/12/2005

Rebetol

Generic Name: ribivarinStatus: Approved
NDA/BLA Holder: Schering PloughNDA/BLA Number: NDA 20-903/S-042, S-043, S-044, S-045, NDA 21-546/S-001NDA/BLA Approval: 6/3/1998, 7/29/2003

Reglan

Generic Name: metoclopramide hydrochlorideStatus: Approved
NDA/BLA Holder: Alaven PharmaceuticalsNDA/BLA Number: NDA 17-854/S-052NDA/BLA Approval: 12/30/1980

Reglan ODT

Generic Name: metoclopramide hydrochlorideStatus: Approved
NDA/BLA Holder: Alvena PharmaceuticalNDA/BLA Number: NDA 21-793/S-005NDA/BLA Approval: 6/10/2005

Remicade

Generic Name: infliximabStatus: Approved
NDA/BLA Holder: CentocorNDA/BLA Number: BLA 103772/5258NDA/BLA Approval: 8/24/1998

Revlimid Capsules

Generic Name: lenalidomideStatus: Approved
NDA/BLA Holder: CelgeneNDA/BLA Number: (NDA) 021880NDA/BLA Approval: 12/27/2005

Roferon-A

Generic Name: Interferon Alfa-2aStatus: Approved
NDA/BLA Holder: Hoffman-LaRocheNDA/BLA Number: BLA 103145NDA/BLA Approval: 06/04/1986

Rozerem Tablets

Generic Name: ramelteonStatus: Approved
NDA/BLA Holder: TakedaNDA/BLA Number: NDA 21-782/S-008, S-009, S-010NDA/BLA Approval: 7/22/2005

Sabril

Generic Name: vigabatrinStatus: Approved
NDA/BLA Holder: LundbeckNDA/BLA Number: NDA 22-006, NDA 20-427NDA/BLA Approval: 8/21/2009

Samsca

Generic Name: tolvaptanStatus: Approved
NDA/BLA Holder: Otsuka America PharmaceuticalNDA/BLA Number: NDA 22-275NDA/BLA Approval: 5/19/2009

Savella Tablets

Generic Name: milnacipran hydrochloride Status: Approved
NDA/BLA Holder: Cypress BioscienceNDA/BLA Number: NDA 22-256NDA/BLA Approval: 1/14/2009

Seroquel

Generic Name: quetiapineStatus: Approved
NDA/BLA Holder: AstraZenecaNDA/BLA Number: NDA 20-639/S-045, S-046NDA/BLA Approval: 9/26/1997

Seroquel XR

Generic Name: quetiapineStatus: Approved
NDA/BLA Holder: AstraZenecaNDA/BLA Number: NDA 22-047/S-011, S-016, S-017, S-019, S-022NDA/BLA Approval: 5/17/2007

Silenor

Generic Name: doxepin hydrochlorideStatus: Approved
NDA/BLA Holder: SomaxonNDA/BLA Number: NDA 22-036NDA/BLA Approval: 03/17/2010

Simponi

Generic Name: golimumabStatus: Approved
NDA/BLA Holder: Centocor Ortho BiotechNDA/BLA Number: BLA 125289NDA/BLA Approval: 4/24/2009

Soliris

Generic Name: eculizumabStatus: Approved
NDA/BLA Holder: Alexion Pharmaceuticals, Inc.NDA/BLA Number: BLA 125166/44NDA/BLA Approval: 3/16/2007

Stelara

Generic Name: ustekinumabStatus: Approved
NDA/BLA Holder: Centocor Ortho BiotechNDA/BLA Number: BLA 125261NDA/BLA Approval: 9/25/2009

Suboxone

Generic Name: buprenorphine; naloxoneStatus: Approved
NDA/BLA Holder: Reckitt BenckiserNDA/BLA Number: NDA 22-410NDA/BLA Approval: 08/30/2010

Sucraid Oral Solution

Generic Name: sacrosidaseStatus: Approved
NDA/BLA Holder: QOL MedicalNDA/BLA Number: NDA 20-772/S-005NDA/BLA Approval: 4/9/1998

Suprep Bowel Prep Kit

Generic Name: sodium sulfate, potassium sulfate, and magnesium sulfateStatus: Approved
NDA/BLA Holder: Braintree LabsNDA/BLA Number: NDA 22-372NDA/BLA Approval: 08/05/2010

Sutent

Generic Name: sunitinib malateStatus: Approved
NDA/BLA Holder: CPPINDA/BLA Number: NDA 21-938NDA/BLA Approval: 01/26/2006

Symbicort Inhalation Aerosol

Generic Name: budesonide and formoterolStatus: Approved
NDA/BLA Holder: AstraZenecaNDA/BLA Number: NDA 21-929/S-012NDA/BLA Approval: 7/21/2006

Symbyax Capsules

Generic Name: olanzapine and fluoxetine Status: Approved
NDA/BLA Holder: Eli LillyNDA/BLA Number: NDA 21-520/S-012NDA/BLA Approval: 12/24/2003

Tapentadol Tablets

Generic Name: Tapentadol TabletsStatus: Approved Not Marketed
NDA/BLA Holder: Ortho McNeil JanssenNDA/BLA Number: NDA 22-304NDA/BLA Approval: 11/20/2008

Tasigna

Generic Name: Nilotinim hydrochloride monohydrateStatus: Orphan
NDA/BLA Holder: NovartisNDA/BLA Number: NDA 22-068NDA/BLA Approval: 10/29/2007

Testim

Generic Name: testosteroneStatus: Approved
NDA/BLA Holder: AuxiliumNDA/BLA Number: NDA 21-454/S-008NDA/BLA Approval: 10/31/2002

Thalomid

Generic Name: thalidomideStatus: Approved
NDA/BLA Holder: CelgeneNDA/BLA Number: NDA 20-785NDA/BLA Approval: 7/16/1998

Topamax Tablets and Sprinkle Capsules

Generic Name: topiramateStatus: Approved
NDA/BLA Holder: Ortho McNeil JanssenNDA/BLA Number: NDA 20-505/S-038, S-039, NDA 20-844/S-032, S-034NDA/BLA Approval: 12/24/1996, 10/26/1998

Tracleer

Generic Name: bosentanStatus: Approved
NDA/BLA Holder: Actelion Pharmaceuticals US, Inc.NDA/BLA Number: NDA 21-290NDA/BLA Approval: 11/20/2001

Tranxene

Generic Name: clorazepate dipotassiumStatus: Approved
NDA/BLA Holder: Lundbeck Inc.NDA/BLA Number: NDA 17-105NDA/BLA Approval: 06/23/1972

Treximet Tablets

Generic Name: sumatriptan succinate and naproxen sodiumStatus: Approved
NDA/BLA Holder: GlaxoSmithKlineNDA/BLA Number: NDA 21-926NDA/BLA Approval: 4/15/2008

Trilipix Delayed-Release Capsules

Generic Name: fenofibric acidStatus: Approved
NDA/BLA Holder: AbbottNDA/BLA Number: NDA 22-224NDA/BLA Approval: 12/15/2008

Trizivir

Generic Name: abacavir sulfate, lamivudine, and zidovudineStatus: Approved
NDA/BLA Holder: GlaxoSmithKlineNDA/BLA Number: NDA 21-205/S-021NDA/BLA Approval: 11/14/2000

Tyzeka Oral Solution

Generic Name: telbivudineStatus: Approved
NDA/BLA Holder: NovartisNDA/BLA Number: NDA 22-154NDA/BLA Approval: 4/28/2009

Tyzeka Tablets

Generic Name: telbivudineStatus: Approved
NDA/BLA Holder: NovartisNDA/BLA Number: NDA 22-011/S-001NDA/BLA Approval: 11/25/2006

Venlafaxine Hydrochloride

Generic Name: venlafaxine hydrochlorideStatus: Approved
NDA/BLA Holder: Osmotica PharmNDA/BLA Number: NDA 22-104NDA/BLA Approval: 5/20/2008

Vibativ

Generic Name: telavancinStatus: Approved
NDA/BLA Holder: TheravanceNDA/BLA Number: NDA 22-110NDA/BLA Approval: 9/11/2009

Victoza

Generic Name: liraglutideStatus: Approved
NDA/BLA Holder: Novo NordiskNDA/BLA Number: NDA 22-341NDA/BLA Approval: 1/25/2010

Videx, Videx EC

Generic Name: didanosineStatus: Approved
NDA/BLA Holder: BMSNDA/BLA Number: NDA 20-156/S-046, NDA 21-183/S-023NDA/BLA Approval: 10/9/1991, 10/23/2000

Vimpat Injection

Generic Name: lacosamide Status: Approved
NDA/BLA Holder: Schwarz BiosciencesNDA/BLA Number: NDA 22-253, 22-254NDA/BLA Approval: 11/28/2008

Viramune Tablets and Oral Suspension

Generic Name: nevirapine Status: Approved
NDA/BLA Holder: Boehringer IngelheimNDA/BLA Number: NDA 20-636/S-027, NDA 20-933/S-017NDA/BLA Approval: 6/21/1996, 9/11/1998

Visicol

Generic Name: sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrateStatus: Approved
NDA/BLA Holder: Salix PharmaceuticalsNDA/BLA Number: NDA 21-097/S-014NDA/BLA Approval: 9/21/2000

Vivitrol

Generic Name: naltrexoneStatus: Approved
NDA/BLA Holder: AlkermesNDA/BLA Number: NDA 21-897NDA/BLA Approval: 04/16/2006

Votrient

Generic Name: pazopanibStatus: Approved
NDA/BLA Holder: GSKNDA/BLA Number: NDA 22-465NDA/BLA Approval: 10/19/2009

Wellbutrin XL

Generic Name: bupropion hydrochlorideStatus: Approved
NDA/BLA Holder: Biovail LabsNDA/BLA Number: NDA 21-515NDA/BLA Approval: 08/29/2003

Wellbutrin, Wellbutrin SR

Generic Name: bupropion hydrochlorideStatus: Approved
NDA/BLA Holder: GSKNDA/BLA Number: NDA 18-644NDA/BLA Approval: 12/30/1985

Xenazine Tablets

Generic Name: tetrabenazineStatus: Approved
NDA/BLA Holder: Biovail AmericasNDA/BLA Number: NDA 21-894NDA/BLA Approval: 8/15/2008

Xeomin

Generic Name: incobotulinumtoxinAStatus: Approved
NDA/BLA Holder: Merz PharmaceuticalsNDA/BLA Number: BLA 125360NDA/BLA Approval: 07/30/2010

Xiaflex

Generic Name: collagenase clostridium histolyticumStatus: Approved
NDA/BLA Holder: AuxiliumNDA/BLA Number: BLA 125338NDA/BLA Approval: 2/2/2010

Xolair

Generic Name: omalizumabStatus: Approved
NDA/BLA Holder: GenentechNDA/BLA Number: BLA 103976/5154NDA/BLA Approval: 6/20/2003

Zarontin

Generic Name: ethosuximideStatus: Approved
NDA/BLA Holder: Parke-DavisNDA/BLA Number: NDA 12-380NDA/BLA Approval: 11/02/1960

Zenpep

Generic Name: pancrelipaseStatus: Approved
NDA/BLA Holder: EurandNDA/BLA Number: NDA 22-210NDA/BLA Approval: 8/27/2009

Ziagen Tablets and Oral Solution

Generic Name: abacavir sulfate Status: Approved
NDA/BLA Holder: GlaxoSmithKlineNDA/BLA Number: NDA 20-977/S-017, NDA 20-978/S-020NDA/BLA Approval: 12/17/1998, 12/17/1998

Zolpimist

Generic Name: zolpidem tartrateStatus: Approved
NDA/BLA Holder: NovadelNDA/BLA Number: NDA 22-196NDA/BLA Approval: 12/19/2008

Zonegran Capsules

Generic Name: zonisamide Status: Approved
NDA/BLA Holder: DainipponNDA/BLA Number: NDA 20-789/S-022, S-025NDA/BLA Approval: 3/27/2000

Zortress

Generic Name: everolimusStatus: Approved
NDA/BLA Holder: NovartisNDA/BLA Number: NDA 21-560NDA/BLA Approval: 04/20/2010

Zyban

Generic Name: bupropion hydrochlorideStatus: Approved
NDA/BLA Holder: GSKNDA/BLA Number: NDA 20-711NDA/BLA Approval: 05/14/1997

Zyprexa Relprevv

Generic Name: olanzapineStatus: Approved
NDA/BLA Holder: Eli LillyNDA/BLA Number: NDA 22-173NDA/BLA Approval: 12/11/2009

Zyprexa, Zyprexa Zydis Tablets

Generic Name: olanzapineStatus: Approved
NDA/BLA Holder: Eli LillyNDA/BLA Number: NDA 20-592/S-039, NDA 21-086/S-021NDA/BLA Approval: 9/30/1996, 4/6/2000

Deemed REMS

ACAM2000

Generic Name: Small pox (Vaccinia) Vaccine, LiveStatus: Approved
NDA/BLA Holder: AcambisNDA/BLA Number: BLA 125158NDA/BLA Approval: 8/31/2007

Accutane

Generic Name: isotretinoinStatus: Approved
NDA/BLA Holder: Hoffman LaRocheNDA/BLA Number: NDA 18-662NDA/BLA Approval: 5/7/1982

Actiq

Generic Name: fentanyl citrateStatus: Approved
NDA/BLA Holder: CephalonNDA/BLA Number: NDA 20-747NDA/BLA Approval: 11/4/1998

Amnesteem

Generic Name: isotretinoinStatus: Approved
NDA/BLA Holder: Hoffman LaRocheNDA/BLA Number: ANDA 75-945NDA/BLA Approval: Nov-02

Claravis

Generic Name: isotretinoinStatus: Approved
NDA/BLA Holder: Barr Pharmaceuticals, Inc. Teva Pharmaceuticals InNDA/BLA Number: ANDA 76-135, ANDA 76-356NDA/BLA Approval: 4/11/2003

Clozaril

Generic Name: clozapineStatus: Approved
NDA/BLA Holder: Novartis Pharmaceuticals Corp.NDA/BLA Number: NDA 19-758NDA/BLA Approval: 9/26/1989

Clozaril

Generic Name: clozapineStatus: Approved
NDA/BLA Holder: Ivax PharmsNDA/BLA Number: ANDA 74-949NDA/BLA Approval: 11/26/1997

Clozaril

Generic Name: clozapineStatus: Approved
NDA/BLA Holder: Mylan LaboratoriesNDA/BLA Number: ANDA 75-417NDA/BLA Approval: 5/27/1999

Clozaril

Generic Name: clozapineStatus: Approved
NDA/BLA Holder: Caraco Pharmaceutical LaboratoriesNDA/BLA Number: ANDA 75-713NDA/BLA Approval: 11/15/2002

Clozaril

Generic Name: clozapineStatus: Discont'd
NDA/BLA Holder: Par PharmNDA/BLA Number: ANDA 75-162NDA/BLA Approval: 4/26/2005

Clozaril

Generic Name: clozapineStatus: Approved
NDA/BLA Holder: GoldlineNDA/BLA Number: ANDA 76-809NDA/BLA Approval: 12/16/2005

Fazaclo ODT

Generic Name: clozapineStatus: Approved
NDA/BLA Holder: Azur Pharma InternationalNDA/BLA Number: NDA 21-590NDA/BLA Approval: 2/9/2004

Ionsys

Generic Name: fentanyl PCAStatus: Approved - Not Available in U.S. Market
NDA/BLA Holder: AlzaNDA/BLA Number: NDA 21-338NDA/BLA Approval: 5/22/2006

Mifeprex

Generic Name: mifepristoneStatus: Approved
NDA/BLA Holder: Danco LaboratoriesNDA/BLA Number: NDA 20-687NDA/BLA Approval: 9/28/2000

Plenaxis

Generic Name: abarelixStatus: Discontinued
NDA/BLA Holder: Speciality EuropeanNDA/BLA Number: NDA 21-320NDA/BLA Approval: 11/25/2003

Revlimid

Generic Name: lenalidomideStatus: Approved
NDA/BLA Holder: CelgeneNDA/BLA Number: NDA 21-880NDA/BLA Approval: 12/27/2005

Sotret

Generic Name: isotretinoinStatus: Approved
NDA/BLA Holder: Hoffman LaRocheNDA/BLA Number: ANDA 76-041, ANDA 76-503NDA/BLA Approval: 12/24/2002, 6/20/2003

Tikosyn

Generic Name: dofetilideStatus: Approved
NDA/BLA Holder: PfizerNDA/BLA Number: NDA 20-931NDA/BLA Approval: 0/01/1999

Tysabri

Generic Name: natalizumabStatus: Approved
NDA/BLA Holder: Biogen IdecNDA/BLA Number: BLA 125104NDA/BLA Approval: 11/23/2004

Xyrem

Generic Name: sodium oxybateStatus: Approved
NDA/BLA Holder: Jazz PharmaceuticalsNDA/BLA Number: NDA 21-196NDA/BLA Approval: 7/17/2002

 

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