WOODCLIFF LAKE, N.J., Sept. 25, 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 glipizide 5 mg and 10 mg extended-release (ER) tablets. Glipizide ER is the generic version of Pfizer's Glucotrol XL® and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Par has begun shipping 5 mg and 10 mg strengths of the product. According to IMS Health data, annual U.S. sales of the 5 mg and 10 mg strengths of glipizide ER are approximately $89 million.
Important Information About Glipizide ER Tablets
Glipizide extended-release tablets are contraindicated in patients with: a known hypersensitivity to glipizide or any excipients in the tablets; and Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
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.