Thursday, December 27, 2012

2013 FDA Drug Approval Decision Calendar

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)Drug/indication: Canagliflozin for diabetes.FDA advisory panel: Jan. 10Approval decision date: March 29

See if (PATH) is in our portfolio

Theravance (THRX)Drug/indication: Vibativ for hospital acquired pneumoniaApproval decision date: Jan. 11Santarus (SNTS)Drug/indication: Uceris for ulcerative colitisApproval decision date: Jan. 16NuPathe (PATH)Drug/indication: Zelrix for migraineApproval decision date: Jan. 17, 2013Impax Labs (IPXL)Drug/indication: IPX066 for Parkinson's diseaseApproval decision date: Jan. 21Hyperion Therapeutics (HPTX)Drug/indication: Ravicti for urea cycle disorderApproval decision date: Jan. 23Sanofi (SNY) and Isis Pharmaceuticals (ISIS)Drug/indication: Kynamro for dyslipidemia/hypercholesterolemiaApproval decision date: Jan. 29, 2013Raptor Pharmaceutical (RPTP)Drug/indication: RP103 for cystinosisApproval decision date: Jan. 30, 2013Hemispherx Biopharma (HEB)Drug/indication: Ampligen for chronic fatigue syndromeApproval decision date: Feb. 1, 2013Celgene (CELG)Drug/indication: Pomalidomide for multiple myelomaApproval decision date: Feb. 8, 2013Dynavax (DVAX)Drug/indication: Heplisav for hepatitis B preventionApproval decision date: Feb. 22, 2013Roche (RHHBY) and Immunogen (IMGN)Drug/indication: T-DM1 for breast cancerApproval decision date Feb. 26Zogenix (ZGNX)Drug/indication: Zohydro for chronic painApproval decision date: March 1, 2013Depomed (DEPO)Drug/indication: Serada for menopauseFDA advisory panel: March 4Approval decision date: May 31Bristol-Myers Squibb (BMY)Drug/indication: Eliquis for blood clot preventionApproval decision date: March 15A.P. Pharma (APPA)Drug/indication: APF530 for chemotherapy induced nauseaApproval decision date: March 27Biogen Idec (BIIB)Drug/indication: BG-12 for multiple sclerosisApproval decision date: March 28MAP Pharma (MAPP)Drug/indication: Levadex for migraineApproval decision date: April 15Sucampo Pharmaceuticals (SCMP)Drug/indication: Amitzia for opioid-induced constipationApproval decision date: April 26Navidea Biopharmaceuticals (NAVB)Drug/indication: Lymphoseek, a radioactive tracing agent for lymph node mappingApproval decision date: April 30GlaxoSmithKline (GSK)Drug/indication: Dabrefenib for melanomaFDA advisory panel: June 3Delcath Systems (DCTH)Drug/indication: ChemoSat for liver metastases due to ocular melanomaApproval decision date: June 14AVEO Pharmaceuticals (AVEO)Drug/indication: Tivozanib for kidney cancerApproval decision date: July 28Companies with drugs filed to FDA but no assigned approval decision dates:Auxillium Pharmaceuticals (AUXL): Xiaflex for Peyronie's diseaseBayer and Algeta: Alpharadin for prostate cancerAntares Pharma (ATRS): Otrexup for rheumatoid arthritisGlaxoSmithKline: Dolutegravir for HIVSources: Company reports, TheStreet research, BioMedTracker>To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. Follow TheStreet on Twitter and become a fan on Facebook.

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