Home » Manufacturing Issues Are Cause of Impax NDA Rejection
Manufacturing Issues Are Cause of Impax NDA Rejection
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
Washington Drug Letter
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