REMS Lawsuit Possible After US FDA Approves Generic Xyrem
FDA waives requirement that Roxane's generic use same REMS as the brand; Jazz ‘intends to evaluate all potential challenges.’ Launch of generic still depends on patent litigation.
You may also be interested in...
Jazz detailed Phase III data on a next-generation narcolepsy drug that could extend the life of its successful Xyrem franchise. The launch of Sunosi also is underway.
Federal Circuit rules that material about Xyrem's REMS distribution system provided for advisory committee review constitutes prior art.
Agency declined to say whether ANDA sponsors would need to meet requirements requested by Sandoz; Mylan's generic user fee date is March 28.