Selected drugs that received regulatory approval in 2012. Source: BCIQ: BioCentury Online Intelligence

Company

Product

Indication

2012 approval

Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR)

Juxtapid lomitapide

Homozygous familial hypercholesterolemia (hoFH)

U.S.

Affymax Inc. (NASDAQ:AFFY)/ Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

Omontys peginesatide

Anemia in chronic kidney disease (CKD) patients who are on dialysis

U.S.

Alexza Pharmaceuticals Inc. (NASDAQ:ALXA)

Adasuve Staccato loxapine

Schizophrenia or bipolar disorder

U.S.

Alimera Sciences Inc(NASDAQ:ALIM)/ pSivida Corp. (NASDAQ:PSDV; ASX:PVA)

Iluvien fluocinolone acetonide

Chronic diabetic macular edema (DME)

Austria/ Portugal/U.K.

Almirall S.A(Madrid:ALM)/Forest Laboratories Inc. (NYSE:FRX)/Menarini Group/Quintiles Transnational Corp.

Tudorza Pressai aclidinium bromide (Bretaris/Eklira Genuair - EU)

Chronic obstructive pulmonary disease (COPD)

EU/U.S.

Amarin Corp. plc (NASDAQ:AMRN)

Vascepa icosapent ethyl

Severe hypertriglyceridemia

U.S.

Amylin Pharmaceuticals LLC/Bristol-Myers Squibb Co. (NYSE:BMY)/Alkermes plc(NASDAQ:ALKS)

Bydureon exenatide once weekly using Alkermes' drug delivery technology

Type II diabetes

U.S.

Arena Pharmaceuticals Inc. (NASDAQ:ARNA)/ Eisai Co. Ltd. (Tokyo:4523; Osaka:4523)

Belviq lorcaserin

Chronic weight management

U.S.

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA)

Iclusig ponatinib

Chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL)

U.S.

Astellas Pharma Inc. (Tokyo:4503)

Myrbetriq mirabegron

Overactive bladder

U.S.

AstraZeneca plc (LSE:AZN; NYSE:AZN)/ Bristol-Myers Squibb Co. (NYSE:BMY)

Forxiga dapagliflozin

Type II diabetes

EU

Bayer AG (Xetra:BAYN)/Onyx Pharmaceuticals Inc. (NASDAQ:ONXX)

Stivarga regorafenib

Metastatic colorectal cancer (mCRC)

U.S.

BioSante Pharmaceuticals Inc. (NASDAQ:BPAX)/ Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA)

Bio-T-Gel testosterone gel

Male hypogonadism

U.S.

BTG plc (LSE:BGC)

Voraxaze glucarpidase

Lower toxic levels of chemotherapy drug methotrexate

U.S.

Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC)

Pixuvri pixantrone

Non-Hodgkin's lymphoma (NHL)

EU (conditional)

Corcept Therapeutics Inc. (NASDAQ:CORT)

Korlym mifepristone

Cushing's syndrome

U.S.

Discovery Laboratories Inc. (NASDAQ:DSCO)

Surfaxin lucinactant

Prevent respiratory distress syndrome in premature infants

U.S.

EffRx Pharmaceuticals S.A./Mission Pharmacal Co./ Merck & Co. Inc. (NYSE:MRK)

Binosto alendronate

Osteoporosis

U.S.

Eisai Co. Ltd. (Tokyo:4523; Osaka:4523)

Fycompa perampanel

Epilepsy

EU / U.S.

Eli Lilly and Co. (NYSE:LLY)

Amyvid florbetapir

Image beta amyloid neuritic plaque density in patients being evaluated for Alzheimer's disease (AD)

U.S.

Exelixis Inc. (NASDAQ:EXEL)

Cometriq cabozantinib

Metastatic medullary thyroid cancer

U.S.

Gedeon Richter Ltd. (Budapest:RICHTER)/ HRA Pharma S.A.

Esmya ulipristal acetate

Moderate to severe uterine fibroids

EU

Genentech Inc./Roche (SIX:ROG; OTCQX:RHHBY)

Perjeta pertuzumab

HER2-positive metastatic breast cancer

Switzerland/U.S.

Genentech Inc./Roche (SIX:ROG; OTCQX:RHHBY)/Curis Inc. (NASDAQ:CRIS)

Erivedge vismodegib

Advanced basal cell carcinoma (BCC)

U.S.

Gilead Sciences Inc. (NASDAQ:GILD)/ Japan Tobacco Inc. (Tokyo:2914; Osaka:2914)

Stribild elvitegravir/cobicistat/ emtricitabine/tenofovir

HIV-1 infection

U.S.

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

Raxibacumab

Treat and prevent inhalational anthrax

U.S.

Incyte Corp. (NASDAQ:INCY)/Novartis AG (NYSE:NVS; SIX:NOVN)

Jakafi ruxolitinib

Myelofibrosis

Canada/EU

Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD)/ Almirall S.A. (Madrid:ALM)/Forest Laboratories Inc. (NYSE:FRX)

Linzess linaclotide (Constella - EU)

Chronic constipation and irritable bowel syndrome with constipation (IBS-C)

EU/U.S.

Johnson & Johnson (NYSE:JNJ)

Sirturo bedaquiline

Multi-drug resistant pulmonary tuberculosis (TB)

U.S.

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151)

Poteligeo mogamulizumab

CC chemokine receptor 4 (CCR4; CD194)-positive T cell leukemia- lymphoma

Japan

MedImmune LLC/AstraZeneca plc (LSE:AZN; NYSE:AZN)

FluMist Quadrivalent (MEDI-3250)

Prevent seasonal influenza

U.S.

Medivation Inc. (NASDAQ:MDVN)/ Astellas Pharma Inc. (Tokyo:4503)

Xtandi enzalutamide

Metastatic castration-resistant prostate cancer (CRPC)

U.S.

Merck & Co. Inc. (NYSE:MRK)

Zioptan tafluprost

Elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension

U.S.

Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508)/Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568)

Tenelia teneligliptin

Type II diabetes

Japan

Napo Pharmaceuticals Inc./Salix Pharmaceuticals Ltd. (NASDAQ:SLXP)

Fulyzaq crofelemer

Non-infectious diarrhea in HIV/AIDS patients on antiretroviral therapy

U.S.

Novartis AG (NYSE:NVS; SIX:NOVN)

Signifor pasireotide

Cushing's disease

EU/U.S.

NPS Pharmaceuticals Inc. (NASDAQ:NPSP)/ Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

Gattex teduglutide (Revestive - EU)

Short bowel syndrome (SBS)

EU/U.S.

Onyx Pharmaceuticals Inc. (NASDAQ:ONXX)

Kyprolis carfilzomib

Multiple myeloma (MM)

U.S.

Pfizer Inc. (NYSE:PFE)

Xeljanz tofacitinib

Moderate to severe rheumatoid arthritis (RA)

U.S.

Pfizer Inc. (NYSE:PFE)

Inlyta axitinib

Advanced renal cell carcinoma (RCC)

EU/U.S.

Pfizer Inc. (NYSE:PFE)

Bosulif bosutinib

Chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) CML

U.S.

Pharmaxis Ltd(ASX:PXS; Pink:PXSLY)

Bronchitol mannitol

Cystic fibrosis (CF)

EU

Protalix Biotherapeutics Inc(NYSE-M:PLX; Tel Aviv:PLX)/Pfizer Inc. (NYSE:PFE)

Elelyso taliglucerase alfa

Type I Gaucher's disease

U.S.

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN)/ Sanofi (Euronext:SAN; NYSE:SNY)

Zaltrap ziv-aflibercept

mCRC

U.S.

Sanofi (Euronext:SAN; NYSE:SNY)

Aubagio teriflunomide

Relapsing forms of multiple sclerosis (MS)

U.S.

Sosei Group Corp. (Tokyo:4565)/ Vectura Group plc (LSE:VEC)/Novartis AG (NYSE:NVS; SIX:NOVN)

Seebri glycopyrronium bromide (NVA237)

COPD

EU/Japan

Supernus Pharmaceuticals Inc. (NASDAQ:SUPN)

Trokendi XR topiramate

Epilepsy

U.S. (tentative)

Supernus Pharmaceuticals Inc. (NASDAQ:SUPN)

Oxtellar XR oxcarbazepine

Epilepsy

U.S.

Talon Therapeutics Inc. (OTCBB:TLON)/ Tekmira Pharmaceuticals Corp. (TSX:TKM; NASDAQ:TKMR)

Marqibo vincristine

Philadelphia chromosome-negative ALL

U.S.

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA)

Synribo omacetaxine mepesuccinate

Chronic or accelerated phase CML

U.S.

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX)

Kalydeco ivacaftor

CF patients with at least one copy of the G551D mutation in the CF transmembrane conductance regulator (CFTR) gene

EU/U.S.

Vivus Inc(NASDAQ:VVUS)

Qsymia phentermine/topiramate

Chronic weight management

U.S.

Vivus Inc. (NASDAQ:VVUS)/Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508)

Stendra avanafil

Erectile dysfunction (ED)

U.S.