Impax Pharmaceuticals, a division of Hayward, Calif.-based Impax Laboratories Inc., announced that the Food and Drug Administration has issued a complete response letter regarding the new drug application for Rytary.
Impax is seeking approval of Rytary, an extended-release capsule formulation of carbidopa-levodopa, for the symptomatic treatment of Parkinson’s disease.
The complete response letter indicates that FDA requires a satisfactory re-inspection of the company’s facility in Hayward as a result of a warning letter issued in 2011 before the NDA may be approved, Impax said. This is because of the facility’s involvement in the development of Rytary, and “supportive manufacturing and ...
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