BRIEF-Impax Laboratories says FDA review date of its experimental Parkinson's drug pushed to Jan. 2013
Oct 12 (Reuters) - Impax Laboratories Inc :
* Impax pharmaceuticals announces extension of rytarytm FDA review date to
January 21, 2013
* Says extended review date from October 21, 2012, to January 21, 2013
* Says no new clinical trials or studies have been requested by the FDA
* Says FDA has extended review date rytary to January 21, 2013
* Source text:
Impax Pharmaceuticals,the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the RytaryTM (IPX066) New Drug Application (NDA) from October 21, 2012, to January 21, 2013.
The FDA notified Impax that its September 28, 2012 submission of requested information on an excipient in the RytaryTM formulation to the FDA has been designated as a major amendment. Since the receipt date of this additional information is within three months of the PDUFA date, the FDA has exercised its option to extend the PDUFA date to review the information. No new clinical trials or studies have been requested by the FDA.
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