Facility Inspection a Sticking Point in Impax's Rytary CRL
By Catherine Shaffer
Wednesday, January 23, 2013
The FDA issued a complete response letter to Impax Pharmaceuticals, of Hayward, Calif., a division of Impax Laboratories Inc., for Rytary (IPX066), indicating that a re-inspection of the company's Hayward facility pursuant to a warning letter issued in May 2011 is necessary before the new drug application (NDA) may be approved.
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