IntelGenx to file NDA amendment in first quarter

IntelGenx Technologies (TSX-V:IGX) has met with the FDA to discuss a complete response letter received in February about its new drug application for its antidepressant CPI-300 and expects to file an amendment to the NDA in the first quarter of 2011. CPI-300 is a novel, high strength of Bupropion HCl, the active ingredient in Wellbutrin [...]

IntelGenx buys back CPI-300 from Cary Pharma

IntelGenx (TSX-V:IGX; OTCBB:IGXT) has acquired full rights to CPI-300, a high-strength formulation of the active ingredient in the antidepressant Wellbutrin XL, from Cary Pharmaceuticals after the companies agreed to terminate their 2007 collaborative development agreement. In addition to certain potential pre-commercialization payments and in the event of CPI-300 being commercialized, IntelGenx will pay Cary 10% [...]

IntelGenx gets bupropion patent in U.S.

IntelGenx (TSX-V:IGX) has received a U.S. patent  for CPI-300, a new formulation of bupropion hydrochloride, the active ingredient in Wellbutrin XL, covering the formulation of pharmaceutical tablets containing sustained-release granules of bupropion HCl distributed in a sustained-release matrix. “The successful issuance of this patent provides formidable intellectual property protection for CPI-300 and further strengthens our [...]

IntelGenx gets FDA complete response letter

IntelGenx Technologies (TSX-V:IGX) has received a complete response letter from the FDA for its new drug application of its antidepressant, CPI-300, which it developed with Cary Pharmaceuticals. The FDA letter lists two main issues that need to be addressed in order to obtain approval, “namely the qualification of a commercial manufacturing site and the food [...]