Manufacturing Issues Are Cause of Impax NDA Rejection

January 30, 2013
The FDA’s rejection of Impax Pharmaceuticals’ extended-release capsule Rytary for the treatment of idiopathic Parkinson’s disease points to continuing problems at a California manufacturing site. On Jan. 22, Impax announced it had received a complete response letter requiring “a satisfactory re-inspection of the company’s Hayward facility … due to the facility’s involvement in the development” of the drug.
Washington Drug Letter