Xyrem REMS Grudgingly Approved; FDA Worries About Blocked Generics

FDA approves a Risk Evaluation & Mitigation Strategy for Jazz Pharmaceutical’s Xyrem under protest; the agency says the single-pharmacy distribution plan for the narcolepsy treatment has the potential to block generic competitors from the market. FDA and Jazz had been working for seven years to agree to a REMS that confirms to the requirements under the FDA Amendments Act of 2007.