| 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.
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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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