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21 Drugs Facing FDA Approval Decisions

Arena Pharmaceuticals (ARNA)

Drug/indication: Lorcaserin for obesity

FDA advisory panel: Sept. 16, 2010

Approval decision date: Oct. 22, 2010

Recent stock performance: At just under $7, the stock has more than doubled since June due to the signing of a marketing partnership with Eisai and the setback to competitor Vivus.

Lorcaserin is one of three obesity drugs currently under review by FDA.


Drug/indication: Avastin for metastatic breast cancer

Approval decision date: Sept. 17, 2010

FDA will decide whether or not to revoke Avastin's approval in breast cancer based on phase III data that failed to demonstrate a survival benefit for patients. Roche has argued that Avastin does benefit breast cancer patients despite the lack of prolonged survival, although a recent FDA advisory panel disagreed.

Novartis (NVS)

Drug/indication: Gilenia for multiple sclerosis

Approval decision date: Sept. 21, 2010

Recent stock performance:Shares are down about 5% for the year.

An FDA advisory panel said Gilenia was safe and effective as a treatment for multiple sclerosis, at a meeting on June 10. If approved, Gilenia would be the first multiple sclerosis drug administered as a pill, and as such, the drug could have an impact on already approved, injectable MS drugs from Biogen Idec (BIIB), Teva (TEVA) and Merck-Serono.

Hospira (HSP)

Drug/indication: Dyloject for acute moderate-to-severe pain in adults

Approval decision date: Oct. 3, 2010

Recent stock performance: At $51, shares are down 15% since hitting a year-high in mid-July.

If approved, Dyloject will be the first IV nonsteroidal anti-inflammatory drug (NSAID) marketed in the U.S. as a single agent for the management of acute moderate-to-severe pain in adults since ketorolac in 1990. The active ingredient in Dyloject is diclofenac sodium, a widely prescribed oral NSAID. Dyloject was developed by Javelin Pharmaceuticals, which Hospira acquired in July.
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