FDA Calendar 12/26/12-03/17/13 03/17/2013 Bris
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Posted On: 12/26/2012 9:25:55 AM
FDA Calendar 12/26/12-03/17/13
03/17/2013 Bristol-Myers Squibb Co. BMY Eliquis (NDA resubmission) FDA decision on Eliquis to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
03/07/2013 GlaxoSmithKline PLC GSK, GSK.L BREO ELLIPTA (NDA) FDA panel to review BREO ELLIPTA for long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.
03/01/2013 Zogenix, Inc. ZGNX Zohydro ER (NDA) FDA decision on Zohydro ER for treating moderate to severe chronic pain
02/26/2013 Immunogen Inc IMGN Trastuzumab emtansine (BLA) FDA decision on Trastuzumab emtansine for breast cancer
02/24/2013 Dynavax Technologies Corp DVAX Heplisav (BLA) FDA decision on Heplisav for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age
02/10/2013 Celgene Corporation CELG Pomalidomide (NDA) FDA decision on Pomalidomide for treatment of relapsed and refractory multiple myeloma
01/30/2013 Raptor Pharmaceuticals Corp. RPTP RP103 (NDA) FDA decision on RP103 for potential treatment of nephropathic cystinosis FDA extends decision date to Apr .30, 2013
01/30/2013 Pharmaxis Ltd PXSLY.PK BRONCHITOL (NDA) FDA panel to review BRONCHITOL for cystic fibrosis
01/29/2013 ISIS Pharmaceuticals Inc ISIS KYNAMRO (NDA) FDAdecision on KYNAMRO for treatment of patients with homozygous familial hypercholesterolemia
01/23/2013 Hyperion Therapeutics, Inc. HPTX Ravicti (NDA) FDA decision on Ravicti for treatment of urea cycle disorder
01/21/2013 Impax Laboratories Inc IPXL IPX066 or Rytary (NDA) FDA decision on Rytary for treatment of idiopathic Parkinson's disease
01/17/2013 NuPathe Inc. PATH Zecuity (formerly known as NP101 and Zelrix) (NDA resubmission) FDA decision on Zecuity for treatment of migraine
01/16/2013 Santarus Inc. SNTS UCERIS (NDA) FDA decision on UCERIS for induction of remission of mild to moderate active ulcerative colitis
01/10/2013 Johnson & Johnson JNJ Canagliflozin (NDA) ( Trade name INVOKANA) FDA panel to review INVOKANA for type 2 diabetes
12/30/2012 NPS Pharmaceuticals Inc NPSP Gattex (NDA) FDA decision on Gattex for treatment of short bowel syndrome in adults FDA approved Gattex for treatment of short bowel syndrome in adults on Dec.21, 2012
03/17/2013 Bristol-Myers Squibb Co. BMY Eliquis (NDA resubmission) FDA decision on Eliquis to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
03/07/2013 GlaxoSmithKline PLC GSK, GSK.L BREO ELLIPTA (NDA) FDA panel to review BREO ELLIPTA for long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.
03/01/2013 Zogenix, Inc. ZGNX Zohydro ER (NDA) FDA decision on Zohydro ER for treating moderate to severe chronic pain
02/26/2013 Immunogen Inc IMGN Trastuzumab emtansine (BLA) FDA decision on Trastuzumab emtansine for breast cancer
02/24/2013 Dynavax Technologies Corp DVAX Heplisav (BLA) FDA decision on Heplisav for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age
02/10/2013 Celgene Corporation CELG Pomalidomide (NDA) FDA decision on Pomalidomide for treatment of relapsed and refractory multiple myeloma
01/30/2013 Raptor Pharmaceuticals Corp. RPTP RP103 (NDA) FDA decision on RP103 for potential treatment of nephropathic cystinosis FDA extends decision date to Apr .30, 2013
01/30/2013 Pharmaxis Ltd PXSLY.PK BRONCHITOL (NDA) FDA panel to review BRONCHITOL for cystic fibrosis
01/29/2013 ISIS Pharmaceuticals Inc ISIS KYNAMRO (NDA) FDAdecision on KYNAMRO for treatment of patients with homozygous familial hypercholesterolemia
01/23/2013 Hyperion Therapeutics, Inc. HPTX Ravicti (NDA) FDA decision on Ravicti for treatment of urea cycle disorder
01/21/2013 Impax Laboratories Inc IPXL IPX066 or Rytary (NDA) FDA decision on Rytary for treatment of idiopathic Parkinson's disease
01/17/2013 NuPathe Inc. PATH Zecuity (formerly known as NP101 and Zelrix) (NDA resubmission) FDA decision on Zecuity for treatment of migraine
01/16/2013 Santarus Inc. SNTS UCERIS (NDA) FDA decision on UCERIS for induction of remission of mild to moderate active ulcerative colitis
01/10/2013 Johnson & Johnson JNJ Canagliflozin (NDA) ( Trade name INVOKANA) FDA panel to review INVOKANA for type 2 diabetes
12/30/2012 NPS Pharmaceuticals Inc NPSP Gattex (NDA) FDA decision on Gattex for treatment of short bowel syndrome in adults FDA approved Gattex for treatment of short bowel syndrome in adults on Dec.21, 2012
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