BIO-Drugs Facing FDA-Approval-FOR-2012-2013

Alexza Pharmaceuticals ALXA (NASDAQ)
Drug/indication: Adasuve for agitation due to schizophrenia
Approval decision date: Dec. 21
This is Alexza's third attempt at Adasuve approval.

Aegerion Pharmaceuticals AEGR (NASDAQ)
Drug/indication: Lomitapide for dyslipidemia/hypercholesterolemia
Approval decision date: Dec. 28

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

NuPathe PATH (NASDAQ)
Drug/indication: Zelrix for migraine
Approval decision date: Jan. 16, 2013
This is NuPathe's second attempt at Zelrix approval.

Sanofi and Isis Pharmaceuticals ISIS (NASDAQ)
Drug/indication: Kynamro for hypercholesterolemia
Approval decision date: Jan. 29, 2013

Raptor Pharmaceutical RPTP (NASDAQ)
Drug/indication: RP103 for cystinosis
Approval decision date: Jan. 30, 2013.

Celgene CELG (NASDAQ)
Drug/indication: Pomalidomide for multiple myeloma
Approval decision date: Feb. 10, 2013.

Dynavax DVAX (NASDAQ)
Drug/indication: Heplisav for hepatitis B prevention
Approval decision date: Feb. 24, 2013

All Approvals
December 2012

http://www.accessdata.fda.gov/scripts/cder/dr...provalsAll