Allos Therapeutics ( ALTH)
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.

Amgen ( AMGN)
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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