MARIETTA, Ga.--(BUSINESS WIRE)--Osmotica Pharmaceutical Corp. today announced the commercial launch of KHEDEZLA (desvenlafaxine) Extended-release (ER) Tablets, 50 mg and 100 mg. Osmotica’s commercial partner Par Pharmaceutical began shipment of the product today. The sales and marketing of KHEDEZLA is supported by Par Pharmaceutical’s Strativa Pharmaceuticals proprietary division. Osmotica 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 in July 2013. KHEDEZLA is indicated for the treatment of major depressive disorder (MDD).
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 Par, Par will market, sell and distribute KHEDEZLA in the United States. Osmotica and Par will share profits from the sales of the product.
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 Osmotica Pharmaceutical
Osmotica Pharmaceutical is a global specialty pharmaceutical company with a proven history of developing commercially successful pharmaceutical products. The company uses its proprietary osmotic technology platform and with strategic partners develops and commercializes high quality pharmaceutical products. In addition to the products currently on the market, the company’s pipeline includes numerous ANDA programs and several innovative neurology-based NDA programs.
Osmotica Pharmaceutical and its related companies form an international group of companies with principal operations located in the United States, Argentina and Hungary.
For more information on the Company, please visit Osmotica’s website at www.osmotica.com.