31 Drugs Facing FDA Approval in 2012-2013

GlaxoSmithKline(GSK) and Ligand Pharmaceuticals(LGND)
Drug/indication: Promacta for thrombocytopenia in hepatitis C patients
Approval decision date: Nov. 30

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

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.

NPS Pharmaceuticals(NPSP)
Drug/indication: Gattex for short bowel syndrome
Approval decision date: Dec. 30

Santarus
Drug/indication: Uceris for ulcerative colitis
Approval decision date: Jan. 16, 2013

NuPathe(PATH)
Drug/indication: Zelrix for migraine
Approval decision date: Jan. 17, 2013
This is NuPathe's second attempt at Zelrix approval.

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

Hemispherx Biopharma(HEB)
Drug/indication: Ampligen for chronic fatigue syndrome
Approval decision date: Feb. 1, 2013

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

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

Zogenix(ZGNX)
Drug/indication: Zohydro for chronic pain
Approval decision date: March 1, 2013

Sanofi(SNY)
Drug/indication: Lemtrada for multiple sclerosis
Approval decision date: April 12, 2013

Johnson & Johnson(JNJ)
Drug/indication: Zytiga for prostate cancer
Approval decision date: April 15, 2013
J&J is seeking an expanded label for Zytiga to treat "pre-chemo" prostate cancer patients.