CPI-300, a novel antidepressant, with a high strength of bupropion hydrochloride (HCl), is the active ingredient in Wellbutrin XL.
Pillar5 has responded to all queries from the FDA for its pre-approval site inspection.
IntelGenx president and CEO Horst Zerbe said they are very excited to have passed another important milestone in their endeavors to bring CPI-300 to market and hopefully make this proprietary product available to patients who suffer from major depressive disorder.
IntelGenx has 10% ownership stake in Pillar5.