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Impax resubmits Rytary NDA

April 12, 2014 12:00 AM UTC

Impax Laboratories Inc. (NASDAQ:IPXL) resubmitted an NDA to FDA for Rytary extended-release carbidopa/levodopa for the symptomatic treatment of Parkinson's disease (PD). The company said the NDA contains updated safety and stability information and that FDA will require an inspection of manufacturing facilities involved in the production of Rytary. In January 2013, FDA issued a complete response letter for the product and said approval would require a "satisfactory re-inspection" of Impax's Hayward, Calif., manufacturing facility (see BioCentury Extra, Jan. 22, 2013). ...