Aurobindo Gets USFDA Nod for Generic Hypertension Tablets

New Delhi: Aurobindo Pharma has received final approval from US health regulator to manufacture and sell in America the generic Telmisartan tablets used for treating hypertension.

"The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Telmisartan tablets USP in the strengths of 20mg, 40mg, and 80mg," Aurobindo Pharma said in a statement.

The approved Abbreviated New Drug Application (ANDA) is bioequivalent to Boehringer Ingelheim Pharmaceuticals Inc's Micardis tablets, it added.

Telmisartan tablets have an estimated market size of $92 million for the 12 months ending July 2015 according to IMS health, Aurobindo Pharma said.

"This is the 46th ANDA to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products," it added.