Roche 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.