IntelGenx Announces New PDUFA Date for Its Single Dose 450 mg Bupropion Hydrochloride Tablet
SAINT LAURENT, QUEBEC--(Marketwire - June 14, 2011) - IntelGenx Corp. (TSX VENTURE:IGX)(OTCBB:IGXT) ("IntelGenx", or "the Company"), announced that the U.S. Food and Drug Administration ("FDA") has accepted the Company's resubmission of its antidepressant CPI-300 New Drug Application 505(b)(2) in response to the February 2010 Complete Response Letter ("CRL") as a complete, Class 2 response. In addition, the FDA has established November 13, 2011 as its target action date under the Prescription Drug User Fee Act ("PDUFA"). CPI-300 is a novel, high strength of Bupropion Hydrochloride (HCl), the active ingredient in Wellbutrin XL®.
"We are very pleased to note that FDA considers our response to be complete," said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "As expected, FDA considers our resubmission a class 2 response to the CRL and, as such, has issued a PDUFA target date of 6 months from the date of our resubmission. We look forward to working with the FDA during the review process and, following approval, making this proprietary product available to patients who suffer from major depressive disorder."
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' research and development pipeline includes products for the treatment of pain, hypertension, erectile dysfunction, sleep disorders, allergies and depressive disorders. More information is available about the company at www.intelgenx.com.
Forward Looking Statements:
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