Par Pharmaceutical Companies, Inc. has received final approval from the US Food and Drug Administration (FDA) 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 US sales of the 5 mg and 10 mg strengths of glipizide ER are approximately $89 million.
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.
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.