First ANDA approval for sodium oxybate (branded as Xyrem) and associated waiver of the requirement for a shared system REMS

First ANDA approval for sodium oxybate (branded as Xyrem) and associated waiver of the requirement for a shared system REMS

On January 17, 2017, the FDA approved the first generic version of Xyrem (sodium oxybate). FDA approved the generic version of Xyrem with a separate REMS, which has the same elements to assure safe use (ETASU) as the Xyrem REMS and is designed to achieve the same level of safety.

After extensive review and consideration, the FDA waived the requirement that the brand drug (Xyrem) and generic drugs utilize a single, shared system for the REMS with ETASU. The Agency has determined that the generic sodium oxybate REMS has the same ETASU as the Xyrem REMS and operationalizes those elements in a comparable manner to the approved Xyrem REMS. 

For additional information, visit Xyrem Information  and FDA approves a generic of Xyrem with a REMS Program