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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
Drug Industry Daily
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