ARTICLE | Company News

Osmotica Pharmaceutical, Pernix Therapeutics sales and marketing update

March 10, 2014 7:00 AM UTC

Osmotica granted Pernix U.S. commercialization rights to 50 and 100 mg Khedezla desvenlafaxine extended-release tablets, which FDA approved in July for major depressive disorder (MDD). The partners will share profits. Khedezla is an extended-release formulation of desvenlafaxine, a serotonin and norepinephrine reuptake inhibitor. The NDA for Khedezla was approved under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. The partners could not be reached for details. ...