Biotech Calendar: Key FDA Action Dates
Drug/indication: Pralatrexate for peripheral T-cell lymphoma
FDA decision date: Sept. 24
Allos expects the FDA to convene an advisory panel meeting to review pralatrexate, although a meeting has not been formally announced. The scheduling of the advisory meeting may delay the FDA's approval decision.
Drug/indication: Denosumab for osteoporosis
FDA advisory panel date: Aug. 13
FDA decision date: Oct. 19
Denosumab is the most important drug in the company's late-stage pipeline. Approval for osteoporosis, and later for certain cancer indications, could re-invigorate earnings growth after a couple of flat years. Denosumab's safety profile will be the focus of the Aug. 13 advisory panel meeting.Acorda Therapeutics (ACOR)
Drug/indication: Fampridine for multiple sclerosis
FDA decision date: Oct. 22 Fampridine improves nerve function and is being developed to improve the walking abilities of patients with multiple sclerosis. GTx (GTXI)
Drug/indication: Acapodene for prostate cancer
FDA decision date: Oct. 30 Acapodene is designed to reduce bone fractures in prostate cancer patients being treated with androgen deprivation therapy. Transcept Pharmaceuticals (TSPT)
Drug/indication: Intermezzo for insomnia
FDA decision date: Oct. 30 Intermezzo is a dissolvable, low-dose form of the sleep aid Ambien which will be marketed for people who awake in the middle of the night but can't fall back to sleep. Cadence Pharmaceuticals (CADX)
Drug/indication: Acetevance for acute pain/fever
FDA decision date: Nov. 13 Acetevance is an injectable form of the painkiller acetaminophen for use in hospitals. Somaxon Pharmaceuticals (SOMX)
Drug/indication: Silenor for insomnia
FDA decision date: Dec. 4 The FDA refused to approve Silenor last February, requesting additional clinical information from Somaxon. The company resubmitted Silenor in June.
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