Jazz Pharmaceuticals will likely have to narrow the proposed indication for its formulation of sodium oxybate for fibromyalgia (JZP-6, also marketed as Xyrem for other indications), as well as sponsoring one or more additional clinical trials and sharpening the proposed Risk Evaluation and Mitigation Strategy. The company was surprised by the scope of the "complete response" letter, CEO Bruce Cozadd said during an Oct. 11 call, although the action itself was anticipated following a negative advisory committee review (1"Jazz Fibromyalgia Candidate Needs More Risk Management, Advisory Panel Tells FDA," "The Pink Sheet" DAILY, Aug. 20, 2010). According to Cozadd, the letter asks for "additional studies to collect data, to evaluate safety in patients who may be taking concomitant medications, and the need for additional information regarding the selection of the appropriate patient population for the product. It also cites the risk of accidental exposure in patient households, particularly given the second dose taken in the middle of the night." The firm also must work on the concentration and trade name
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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