| Date | Company Name | Ticker | Drug | Event | Outcome | Details |
| 12/29/2009 | Cephalon Inc | CEPH | Nuvigil (sNDA) | FDA action on Nuvigil as a treatment to improve wakefulness in patients with jet lag |
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| 12/27/2009 | Pharmaxis Ltd | PXSLY.PK | Aridol (NDA) | FDA action on Aridol as a mannitol bronchial challenge test to diagnose and assess asthma |
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| 12/12/2009 | VION PHARMACEUTICALS INC | VION.OB | Onrigin (NDA) | FDA action on Onrigin for acute myeloid leukemia |
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| 12/04/2009 | Somaxon Pharmaceuticals, Inc. | SOMX | Silenor (Amended NDA) | FDA action on Silenor for treatment of insomnia |
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| 12/04/2009 | Santarus Inc. | SNTS | New tablet formulation of Zegerid (NDA) | FDA action on new tablet formulation of Zegerid |
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| 12/01/2009 | Dyax Corp | DYAX | DX-88 (Amended BLA) | FDA action on DX-88 for treatment of acute attacks of hereditary angioedema |
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| 11/26/2009 | THERAVANCE, INC. | THRX | Vibativ (NDA) | FDA action on Vibativ for hospital-acquired pneumonia |
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| 11/22/2009 | CombinatoRx, Incorporated | CRXX | Exalgo (NDA) | FDA action on Exalgo for chronic to severe pain |
On Nov.16, the FDA staff said that NDA for Exalgo in its current form would not be sufficient to form the
basis for approval.
On Nov.20, FDA extended action date to February 22, 2010 to complete its review of the Exalgo NDA.
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| 11/16/2009 | NeurogesX Inc | NGSX | Qutenza (NDA) | FDA action on Qutenza for pain associated with postherpetic neuralgia |
FDA approves Qutenza for pain associated with postherpetic neuralgia
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| 11/13/2009 | CADENCE PHARMACEUTICALS INC. | CADX | Acetavance (NDA) | FDA action on Acetavance for acute pain and fever in adults and children |
FDA's action date extended to February 12, 2010.
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| 11/04/2009 | Covidien Ltd. | COV | Pennsaid (Amended NDA) | FDA action on Pennsaid for osteoarthritis of the knee |
FDA approved Pennsaid for osteoarthritis of the knee on Nov.5
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| 10/30/2009 | GTX INC | GTXI | Toremifene 80mg (NDA) | FDA action on Toremifene 80mg for bone fractures in men with prostate cancer on androgen deprivation therapy |
FDA issued complete response letter for toremifene 80 mg on Nov.2. Sought additional information to address two clinical deficiencies
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| 10/30/2009 | Transcept Pharmaceuticals, Inc. | TSPT | Intermezzo (NDA) | FDA action on Intermezzo for insomnia when a middle of the night awakening is followed by difficulty returning to sleep |
FDA issued complete response letter for Intermezzo on Oct.29. The regulatory agency has sought additional data.
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| 10/27/2009 | Human Genome Sciences Inc | HGSI | ABthrax (BLA) | FDA Advisory Committee to review ABthrax for treatment of inhalational anthrax disease |
FDA panel voted 17 to 6 to recommend submission of more data to determine the effectiveness of ABthrax. In a separate vote, the same panel voted 16 to 7 that animal studies could be used to predict ABthrax’ response in humans
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| 10/22/2009 | Acorda Therapeutics Inc. | ACOR | Fampridine-SR (NDA) | FDA action on Fampridine-SR for improvement of walking ability in people with multiple sclerosis |
FDA decision date extended to Jan.22, 2010
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