Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (IPXL), Monday said it received a complete response letter from U.S. Food and Drug Administration on its New Drug Application or NDA for Rytary. FDA has requested for a satisfactory re-inspection of the company's Hayward facility before the approval.
Earlier, FDA has issued a warning letter in May 2011 and during the assessment of the NDA, the company has withdrawn the Hayward site as an alternative site of commercial production.
FDA issues complete response letters to communicate that a new drug application or abbreviated new drug application to market a new or generic drug will not be approved in its present form.
Rytary is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson's disease, currently under review in the United States.
Larry Hsu, president and CEO of Impax Laboratories said,."We will work with the FDA on the appropriate next steps for the RYTARY application."
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