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2014 FDA Drug Approval Calendar


NEW YORK (TheStreet) -- It's been awhile since I updated the FDA drug approval calendar. Here's the latest list of drugs under FDA review. Included as well are relevant FDA advisory panel dates. 


May 2014:

Biogen Idec  (BIIB)
Plegridy for multiple sclerosis
May 21

Eli Lilly  (LLY)and Dyax (DYAX)
Ramucirumab for gastric cancer
May 23

Durata Therapeutics (DRTX) 
Dalbavancin for skin infections
May 26
(An FDA advisory panel in March voted to recommend approval.)

Omeros (OMER)
OMS302 for ocular inflammation
May 30

June 2014: 

BioDelivery Sciences  (BDSI)
Bunavail for opioid addiction
June 6

Exact Sciences (EXAS)
Cologuard for colon cancer screening
June 6 

Keryx Pharmaceuticals  (KERX)
Zerenex for hyperphosphatemia (kidney dialysis)
June 6

Orexigen Therapeutics (OREX)
Contrave for obesity
June 10 

June 11-12
FDA advisory committee meeting to discuss treatments for opioid-induced constipation
AstraZeneca (AZN) and Nektar Therapeutics (NKTR) - naloxogel
Salix Pharma (SLXP) -- Relistor

Biogen Idec 
Eloctate for hemophilia A
June 12

Cubist Pharma  (CBST)
Tedizolid for skin infections
June 20

July 2014: 

MannKind  (MNKD)
Afrezza for diabetes
July 15

July 24
FDA advisory panel
NPS Pharmaceuticals (NPSP)
Natpara for hypoparathyroidism July 24

Anacor Pharma
Tavaborole for toe fungus
July 29

August 2014: 

Medicines Co. (MDCO)
Oritavancin for skin infections (MRSA)
Aug. 6

Spectrum Pharmaceuticals (SPPI)
Belinostat for peripheral T-cell lymphoma
Aug. 8

Regeneron Pharmaceuticals (REGN)
Eylea for diabetic macular edema (expansion of label)
Aug. 18

September 2014: 

Gilead Sciences (GILD)
Idelalisib for indolent non-Hodgkin's lymphoma 
Sept. 11 (pending FDA acceptance of priority review)

AstraZeneca and Nektar Therapeutics
Naloxegol for opioid-induced constipation
Sept. 16

Celgene (CELG)
Otezla for psoriasis (expansion of label)
Sept. 23

October 2014: 

NPS Pharmaceuticals  (NPSP)
Natpara for hypoparathyroidism
Oct. 24

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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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