Savient Pharmaceuticals ( SVNT) Drug/indication: Krystexxa for gout Approval decision date: Sept. 14, 2010 Recent stock performance:At around $14, the stock is up about 30% since early June. The FDA refused to approve Krystexxa last August, citing problems with the way the drug is manufactured. Savient revised the Krystexxa manufacturing process and submitted a response in March to the FDA's complete response letter.
Alkermes ( ALKS) Drug/indication:Vivitrol for opioid addiction FDA advisory panel: Sept. 16, 2010 Approval decision date: Oct. 12, 2010 Recent stock performance:At just under $14, the stock is up about 45% for the year. If approved, Vivitrol will be the first long-acting, non-narcotic treatment for patients addicted to opioids. Alkermes currently sells a version of Vivitrol for alcholol dependence.