Aurobindo Pharma receives US FDA approval for Telmisartan tabs

Telmisartan tablets are indicated in the treatment of essential hypertension

Aurobindo Pharma has received the final approval from the US Food & Drug Administration (US FDA) to manufacture and market Telmisartan tablets USP 20 mg, 40 mg, and 80 mg (ANDA 206511).

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Micardis tablets of Boehringer Ingelheim Pharmaceuticals. Telmisartan tablets are indicated in the treatment of essential hypertension and has an estimated market size of $92 million for the twelve months ending July 2015 according to IMS.

This is the 46th ANDA to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products. Aurobindo now has a total of 211 ANDA approvals (183 Final approvals including nine from Aurolife Pharma and 28 tentative approvals) from US FDA.