IntelGenx Corp. today announced with excitement that the U.S. Food and Drug Administration (FDA) has approved its lead product, CPI-300, for patients with Major Depressive Disorder. CPI-300 is a novel, high-strength formulation of Bupropion hydrochloride (HCl), the active ingredient in Wellbutrin XL. According to the company’s press release, CPI-300 is the only single dose 450 mg formulation of Bupropion HCl approved by the FDA.
“This is a defining moment for IntelGenx, as we have now clearly demonstrated our ability to independently take a product through development to regulatory approval,” stated Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. “We believe physicians will embrace CPI-300 as a more convenient and safe alternative for their patients requiring high-dose anti-depressant therapy. So we now turn our focus towards the commercialization of CPI-300, with the objective of a product launch with a partner by the second quarter of 2012.”
IntelGenx said it has been engaged in licensing discussions with several leading generic and specialty pharmaceutical companies and anticipates finalizing a commercialization agreement soon. As announced previously, the company has already entered into an agreement with Pillar5 Pharma Inc. for the commercial manufacturing of the product.
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