Osmotica Pharmaceutical, Par Pharmaceutical sales and marketing update

Osmotica said U.S. commercialization partner Par launched 50 and 100 mg Khedezla desvenlafaxine extended-release tablets to treat major depressive disorder (MDD). In July, FDA approved the extended-release formulation of a serotonin and norepinephrine reuptake inhibitor. The NDA was submitted 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 company could not be reached for details. ...