Drug/indication: Enzalutamide (MDV3100) for prostate cancer
Approval decision date: Nov. 22
Drug/indication: Adasuve for agitation due to schizophrenia
Approval decision date: Dec. 21
This is Alexza's third attempt at Adasuve approval.
Drug/indication: BG-12 for multiple sclerosis
Approval decision date: Dec. 28
BG-12 would be Biogen's first pill for multiple sclerosis.
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 - Get Report)
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. Sources: Company reports, TheStreet research, BioMedTracker --Written by Adam Feuerstein in Boston.
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