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2013 FDA Drug Approval Calendar

Drug/indication: Dolutegravir, HIV
Approval decision date: Aug. 17

Drug/indication: Trametenib, melanoma
Approval decision date: Sept. 3

Auxilium Pharmaceuticals (AUXL)
Drug/indication: Xiaflex, Peyronie's Disease
Approval decision date: Sept. 6

Delcath Systems (DCTH)
Drug/indication: Meblez, liver tumors due to ocular melanoma
Approval decision date: Sept. 13

Seattle Genetics (SGEN)
Drug/indication: Adcetris, retreatment of Hodgkin's lymphoma
Approval decision date: Sept. 14

Antares Pharma (ATRS - Get Report)
Drug/indication: Otrexup, rheumatoid arthritis
Approval decision date: Oct. 14

Alimera Sciences (ALIM), Psivida (PSDV)
Drug/indication: Iluvien, diabetic macular edema
Approval decision date: Oct. 17

AMAG Pharmaceuticals (AMAG)
Drug/indication: Feraheme, iron deficient anemia
Approval decision date: Oct. 21

Cubist Pharmaceuticals (CBSST)
Drug/indication: Entereg, post-operative constipation
Approval decision date: Oct. 21

Gilead Sciences
Drug/indication: Sofosbuvir, hepatitis C
Approval decision date: Dec. 6

Drug/indication: Vascepa, mixed dyslipidemia
Approval decision date: Dec. 20

Calendar compiled with assistance from BioMedTracker, company reports and TheStreet research.

-- Reported by Adam Feuerstein in Boston.

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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