Par Pharmaceutical Companies, Inc., an US-based specialty pharmaceutical company, has begun shipping Khedezla (desvenlafaxine) extended-release (ER) tablets, 50 mg and 100 mg.  Par’s development partner, Osmotica Pharmaceutical Corp., received approval for its New Drug Application (NDA) for Khedezla ER tablets from the US Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.  

Khedezla is indicated for the treatment of major depressive disorder (MDD).  Khedezla provides patients and physicians with additional options in the treatment of major depressive disorder.

Osmotica’s NDA included comparative bioequivalence testing against Pfizer’s Pristiq (desvenlafaxine) extended-release tablets.  Khedezla is not generically substitutable for Pristiq 50 mg and 100 mg tablets.  According to IMS Health data, annual US sales of Pristiq are approximately $614 million.

Under terms of its agreement with Osmotica, Par will market, sell and distribute Khedezla in the United States.  Par will share profits from the sales of the product with its development partner.  

Par Pharmaceutical Companies, Inc. is a privately held, US-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary’s two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals.