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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.



>To contact the writer of this article, click here: Adam Feuerstein.

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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
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