Aurobindo Receives FDA Approval for Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Glucotrol® XL Tablets, of Pfizer.

Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg is indicated in for the treatment of diabetes.

The product has an estimated market size of $70.3M for the twelve months ending March 2017 according to IMS*.

Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg represents the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 264 final approvals, including 35 tentative approvals, and 16 approved products from Aurolife. There are 104 additional products on file with U.S. FDA.

* IMS National Sales Perspectives: Retail and Non-Retail MAT March 2017