11:42 AM EST - IntelGenx Corp. : announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration regarding the Company's New Drug Application or "NDA" for its antidepressant CPI-300, which it developed with Cary Pharmaceuticals. CPI-300 is a novel, high strength of Bupropion HCl, the active ingredient in Wellbutrin XL. The FDA issues Complete Response Letters to request additional information needed to complete the review of an NDA. The Complete Response Letter lists two main issues which need to be addressed in order to obtain approval, namely the qualification of a commercial manufacturing site and the food effect, which was observed both in CPI-300 and the reference product in the food effect study submitted as part of the NDA. Other than these two issues, which management believes can be effectively addressed, the FDA found no other notable deficiencies in the NDA. IntelGenx Corp.
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