WOODCLIFF LAKE, N.J., Oct. 7, 2013 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for clonidine hydrochloride (HCl) 0.1 mg extended-release (ER) tablets. Clonidine HCl ER is the generic version of Concordia's Kapvay® and is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.
Par has begun shipping the 0.1 mg strength of the product. According to IMS Health data, annual U.S. sales of Kapvay are approximately $72 million.
Important Information About Clonidine HCl ER Tablets
Clonidine hydrochloride extended-release tablets are contraindicated in patients with a known hypersensitivity to clonidine.
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.