Impax Pharma resubmits NDA for Rytary

11 April 2014

Impax Laboratories’ (Nasdaq: IPXL) branded products division has resubmitted the New Drug Application for Rytary (carbidopa and levodopa; IPX066) to the US Food and Drug Administration, for the symptomatic treatment of Parkinson's disease (PD).

Last year, the FDA issued a complete response letter regarding the Impax Pharmaceuticals’ NDA for Rytary, indicating that the FDA required a satisfactory re-inspection of the company’s facility in Hayward, California, as a result of the warning letter issued in May 2011 before the company’s NDA may be approved due to the facility’s involvement in the development of Rytary and supportive manufacturing and distribution activities (The Pharma Letter January 22, 2013).

FDA will require inspection of production facility

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