East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1000 mg. Aurobindo’s Niacin Extended-Release Tablets USP are an AB-rated generic equivalent to the reference listed drug NIASPAN®.

Niacin Extended-Release tablets are indicated to reduce elevated TC, LDL-C, Apo B and TG and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia and to reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. Additionally, indicated to slow progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia.

The product has an estimated market size of $126.3M for the twelve months ending December 2017 according to IMS*.

Niacin Extended-Release Tablets USP represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 289 final approvals, including 38 tentative approvals, and 17 approved products from Aurolife. There are 106 additional products on file with U.S. FDA.

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