| Date | Company Name | Ticker | Drug | Event | Outcome | Details |
| 08/12/2012 | Talon Therapeutics, Inc. | TLON.OB | Marqibo (NDA) | FDA decision on Marqibo in the proposed treatment of adult Philadelphia chromosome-negative acute lymphoblastic leukemia |
|
|
| 08/04/2012 | Regeneron Pharmaceuticals | REGN | Zaltrap (BLA) | FDA decision on Zaltrap for proposed use in metastatic colorectal cancer |
|
|
| 07/27/2012 | Salix Pharmaceuticals Ltd | SLXP | RELISTOR (sNDA) | FDA decision on RELISTOR subcutaneous injection in addnl indication of treating opioid-induced constipation (OIC) in patients with non-cancer pain |
|
|
| 07/26/2012 | Horizon Pharma Inc | HZNP | LODOTRA (NDA) | FDA decision on LODOTRA for treatment of rheumatoid arthritis in adults |
|
|
| 07/26/2012 | Amarin Corp Plc | AMRN | AMR101 (NDA) | FDA decision on AMR101 as treatment for very high triglycerides (greater than or equal to 500mg/dL) |
|
|
| 06/29/2012 | Astellas Pharma Inc. | ALPMY.PK, ALPMF.PK | Mirabegron (NDA) | FDA decision on Mirabegron for proposed treatment of overactive bladder |
|
|
| 06/28/2012 | Bristol-Myers Squibb Co. | BMY | ELIQUIS (NDA) | FDA decision on ELIQUIS for prevention of stroke and systemic embolism in patients with atrial fibrillation |
|
|
| 06/27/2012 | Arena Pharmaceutical Inc. | ARNA | Lorcaserin (NDA) | FDA decision on Lorcaserin for proposed treatment of obesity |
|
|
| 06/21/2012 | Repligen Corp | RGEN | SecreFlo (NDA) | FDA decision on SecreFlo for detection of pancreatic duct abnormalities |
FDA expected to issue complete response letter
|
|
| 06/20/2012 | Sanofi-Aventis | SNY, SNYNF.PK | Semuloparin (NDA) | FDA panel to review proposed use of Semuloparin in reducing risk of venous thromboembolism in people undergoing certain cancer treatments |
|
|
| 06/20/2012 | Onyx Pharmaceuticals Inc. | ONXX | Kyprolis (NDA) | FDA panel to review Kyprolis for treatment of patients with relapsed and refractory multiple myeloma |
|
|
| 06/10/2012 | Navidea Biopharmaceuticals, Inc. | NEOP, NAVB | Lymphoseek (NDA) | FDA decision on Lymphoseek for proposed use in intraoperative lymphatic mapping |
FDA decision date postponed to September 10, 2012
|
|
| 06/08/2012 | XENOPORT INC | XNPT | Horizant (sNDA) | FDA decision on Horizant in addnl indication of post-herpetic neuralgia |
|
|
| 06/05/2012 | Salix Pharmaceuticals Ltd | SLXP | Crofelemer 125 mg tablets (NDA) | FDA decision on Crofelemer for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy |
FDA extends decision date by 3 months to September 5
|
|
| 05/31/2012 | Repligen Corp | RGEN | SecreFlo (NDA) | FDA panel to review SecreFlo for detection of pancreatic duct abnormalities |
FDA Advisory Committee meeting cancelled; Complete response letter expected
|
|