Impax Denied Parkinson’s Drug Approval Over Plant Issues

Law360, New York (January 22, 2013, 5:35 PM EST) -- The U.S. Food and Drug and Administration on Monday refused to approve Impax Laboratories Inc.’s proposed Parkinson’s disease treatment Rytary, saying it needed evidence the company had improved testing conditions at a California manufacturing plant before authorizing the drug.

According to a statement by Impax, the FDA had indicated that it required a satisfactory re-inspection of the company’s Hayward, Calif., production plant, the subject of a May 2011 warning letter from the agency over allegedly lax testing practices and one of the facilities used in the...
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