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Friday, December 18, 2009 1:03:06 PM
IGXT.OB
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http://www.intelgenx.com/products/pipeline.html
IntelGenx Corp. Announces FDA Acceptance for Filing of NDA for CPI-300 Antidepressant
On Tuesday June 23, 2009, 6:00 am EDT
IntelGenx Corp. (TSX-V: IGX)(OTC.BB: IGXT) ("IntelGenx") today announced that the New Drug Application filing for their antidepressant CPI-300 has been accepted by the U.S. Food and Drug Administration (FDA) for standard review. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, IntelGenx expects the FDA will complete its review or otherwise respond to the NDA by February 6, 2010.
"Formal FDA acceptance of the NDA clears the path towards review and approval of CPI-300 within the timeframe expected" said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "We are especially pleased to note that the FDA has confirmed that our NDA was sufficiently complete to permit a substantive review. As CPI-300 represents our very first NDA, this is not only a testament to the expertise of our staff but also to the strength of our partners."
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