29 Drugs Facing FDA Approval in 2012

Vivus (VVUS)
Drug/indication: Qnexa for obesity
Approval decision date: July 17
A February FDA advisory panel voted 20-2 to support Qnexa's approval. FDA's decision was delayed by three months to allow the company and regulators to finalize a risk-management plan.

Amarin (AMRN)
Drug/indication: AMR101 for treatment of patients with very high triglycerides
Approval decision date: July 26

Horizon Pharma (HZNP)
Drug/indication: Lodotra for rheumatoid arthritis
Approval decision date: July 26

Progenics (PGNX) and Salix Pharmaceuticals (SLXP)
Drug/indication: Relistor SC for opioid-induced constipation
Approval decision date: July 27

Regeneron Pharmaceuticals and Sanofi (SNY)
Drug/indication: Zaltrap for colon cancer
Approval decision date: Aug. 4
Zaltrap has posted mixed results in phase III clinical trials.

Ironwood Pharmaceuticals (IRWD)
Drug/indication: Linaclotide for chronic idiopathic constipation and irritable bowel syndrome
Approval decision date: Sept. 8

Navidea Biopharmaceuticals (NAVB)
Drug/indication: Lymphoseek, a radioactive tracing agent for lymph node mapping
Approval decision date: Sept. 10

Regeneron Pharmaceuticals
Drug/indication: Eylea for retinal vein occlusion
Approval decision date: Sept. 21
This is an expanded approval for Eylea, already approved for macular degeneration.

NPS Pharmaceuticals (NPSP)
Drug/indication: Gattex for short bowel syndrome
Approval decision date: Sept. 28

Sanofi and Isis Pharmaceuticals (ISIS)
Drug/indication: Kynamro for hypercholesterolemia
Approval decision date: Sept. 28

Raptor Pharmaceutical (RPTP)
Drug/indication: RP103 for cystinosis
Approval decision date: Oct. 1

Celgene
Drug/indication: Abraxane for non-small cell lung cancer
Approval decision date: Oct. 12
Abraxane is already approved for the treatment of breast cancer.

Santarus (SNTS)
Drug/indication: Uceris for ulcerative colitis
Approval decision date: Oct. 16

Impax Labs (IPAX)
Drug/indication: IPX066 for Parkinson's disease
Approval decision date: Oct. 19

Dynavax (DVAX)
Drug/indication: Heplisav for hepatitis B prevention
Approval decision date: Oct. 26

United Therapeutics (UTHR)
Drug/indication: Oral Remodulin for pulmonary arterial hypertension
Approval decision date: Oct. 26

Cornerstone Therapeutics (CRTX)
Drug/indication: Lixivaptan for hyponatremia
Approval decision date: Oct. 29

Celgene
Drug/indication: pomalidomide for refractory/relapsed multiple myeloma
Approval decision date: Fourth quarter
Celgene announced submission of the pomalidomide filing during the second quarter.

Biogen Idec (BIIB)
Drug/indication: BG-12 for multiple sclerosis
Approval decision date: Dec. 28
BG-12 would be Biogen's first pill for multiple sclerosis.

--Written by Adam Feuerstein in Boston.



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