FDA issues Complete Response Letter regarding Rytary (Impax Pharma) for Parkinsons disease
Impax Pharmaceuticals, a division of Impax Laboratories, Inc. has announced that the FDA has issued a Complete Response Letter regarding the New Drug Application (NDA) for Rytary (IPX066), an extended-release capsule formulation of carbidopa-levodopa, a potential treatment for the symptomatic treatment of Parkinson's disease currently under review in the United States.
The Complete Response Letter indicates that the FDA requires a satisfactory re-inspection of the company's Hayward facility 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.
GSK received an exclusive license to register and commercialize IPX066 throughout the world except in the U.S. and Taiwan.
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