FDA Holds Up Impax Parkinson's Drug Approval Bid

In a press statement released Monday, biotech firm Impax Laboratories (NASDAQ: IPXL  ) announced that the FDA has given the company a response to its New Drug Application for Rytary, the company's aspiring sustained-release Parkinson's Disease treatment, asking for a reinspection of Impax's development plant in Hayward, Calif. According to Impax, the FDA previously issued a warning letter about the facility back in 2011.

Impax CEO and president Larry Hsu was quoted in the statement as saying, "We will work with the FDA on the appropriate next steps for the RYTARY application ... We remain committed to resolving the warning letter and bringing this new treatment option to patients who are suffering from Parkinson's disease."

Should Rytary be approved, estimates have pegged peak sales of the drug between $200 million and $300 million annually. Impax will market and sell the drug in the U.S. and Taiwan, while GlaxoSmithKline (NYSE: GSK  ) will handle such duties in other international regions.

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