2013 FDA Drug Approval Decision Calendar
BOSTON (
) -- Here's an updated list of biotech and pharmaceutical companies with FDA drug approval decisions expected in 2013.
Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst -- FDA drug approval decisions and advisory panels.
Johnson & Johnson
(JNJ) - Get Report
Drug/indication:
Canagliflozin for diabetes.
FDA advisory panel:
Jan. 10
Approval decision date:
March 29
Theravance
(THRX)
Drug/indication:
Vibativ for hospital acquired pneumonia
Approval decision date:
Jan. 11
Santarus
(SNTS)
Drug/indication:
Uceris for ulcerative colitis
Approval decision date:
Jan. 16
NuPathe
(PATH)
Drug/indication:
Zelrix for migraine
Approval decision date:
Jan. 17, 2013
Impax Labs
(IPXL)
Drug/indication:
IPX066 for Parkinson's disease
Approval decision date:
Jan. 21
Hyperion Therapeutics
(HPTX)
Drug/indication:
Ravicti for urea cycle disorder
Approval decision date:
Jan. 23
Sanofi
(SNY) - Get Report
and
Isis Pharmaceuticals
(ISIS)
Drug/indication:
Kynamro for dyslipidemia/hypercholesterolemia
Approval decision date:
Jan. 29, 2013
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) - Get Report
Drug/indication:
Pomalidomide for multiple myeloma
Approval decision date:
Feb. 8, 2013
Dynavax
(DVAX) - Get Report
Drug/indication:
Heplisav for hepatitis B prevention
Approval decision date:
Feb. 22, 2013
Roche
(RHHBY)
and
Immunogen
(IMGN) - Get Report
Drug/indication:
T-DM1 for breast cancer
Approval decision date
Feb. 26
Zogenix
(ZGNX) - Get Report
Drug/indication:
Zohydro for chronic pain
Approval decision date:
March 1, 2013
Depomed
(DEPO)
Drug/indication:
Serada for menopause
FDA advisory panel:
March 4
Approval decision date:
May 31
Bristol-Myers Squibb
(BMY) - Get Report
Drug/indication:
Eliquis for blood clot prevention
Approval decision date:
March 15
A.P. Pharma
(APPA)
Drug/indication:
APF530 for chemotherapy induced nausea
Approval decision date:
March 27
Biogen Idec
(BIIB) - Get Report
Drug/indication:
BG-12 for multiple sclerosis
Approval decision date:
March 28
MAP Pharma
( MAPP)
Drug/indication:
Levadex for migraine
Approval decision date:
April 15
Sucampo Pharmaceuticals
(SCMP)
Drug/indication:
Amitzia for opioid-induced constipation
Approval decision date:
April 26
Navidea Biopharmaceuticals
(NAVB) - Get Report
Drug/indication:
Lymphoseek, a radioactive tracing agent for lymph node mapping
Approval decision date:
April 30
GlaxoSmithKline
(GSK) - Get Report
Drug/indication:
Dabrefenib for melanoma
FDA advisory panel:
June 3
Delcath Systems
(DCTH)
Drug/indication:
ChemoSat for liver metastases due to ocular melanoma
Approval decision date:
June 14
AVEO Pharmaceuticals
(AVEO) - Get Report
Drug/indication:
Tivozanib for kidney cancer
Approval decision date:
July 28
Companies with drugs filed to FDA but no assigned approval decision dates:
Auxillium Pharmaceuticals
(AUXL)
: Xiaflex for Peyronie's disease
Bayer
and
Algeta
: Alpharadin for prostate cancer
Antares Pharma
(ATRS) - Get Report
: Otrexup for rheumatoid arthritis
GlaxoSmithKline: Dolutegravir for HIV
Sources: Company reports,
TheStreet
research,
--Written by Adam Feuerstein in Boston.
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