Impax’s Parkinson’s Drug NDA Rejected Due to Manufacturing Issues

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 Monday, 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.
Drug Industry Daily