WOODCLIFF LAKE, N.J., Sept. 23, 2013 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that it 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 U.S. 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 U.S. 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.
Important Information about KHEDEZLA ER Tablets
A black box warning is associated with this product regarding increased risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants. All persons taking KHEDEZLA should be monitored for worsening and emergence of suicidal thoughts and behaviors. KHEDEZLA is not approved for use in pediatric patients. Refer to full prescribing information for complete boxed warning.
KHEDEZLA (desvenlafaxine) Extended-release Tablets are contraindicated in patients who are hypersensitive to desvenlafaxine succinate, venlafaxine hydrochloride or to any component of the product. Angioedema has been reported in patients treated with desvenlafaxine.
The use of MAOIs intended to treat psychiatric disorders with KHEDEZLA or within 7 days of stopping treatment with KHEDEZLA is contraindicated because of an increased risk of serotonin syndrome. The use of KHEDEZLA within 14 days of stopping a MAOI intended to treat psychiatric disorders is also contraindicated. Starting KHEDEZLA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a privately held, U.S.-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. For press release and other company information, visit www.parpharm.com.
SOURCE Par Pharmaceutical Companies, Inc.