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. The news is only the most recent in a long list of issues between Impax and the FDA over the California plant.

In May 2011, the FDA issued a warning letter for deviations in sampling and testing of in-process materials and drug products at the Hayward facility that resulted in a recall of fenofibrate capsules.

Under the latest PDUFA, the FDA has five new criteria for choosing facilities to inspect – are you more likely to be inspected next? Will you be ready?

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