Aurobindo Pharma’s hypertension drug, the generic Telmisartan tablets in the strengths of 20 mg, 40 mg, and 80 mg, has got an approval from the USFDA.
Telmisartan tablets, which will be manufactured and marketed by Aurobindo Pharma in the US market are indicated in the treatment of essential hypertension and has an estimated market size of USD 92 million for the 12 months ending July 2015 according to IMS health, Aurobindo Pharma said.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent to Boehringer Ingelheim Pharmaceuticals Inc’s Micardis tablets, it added.
“This is the 46th ANDA to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non- antibiotic products,” it added.
Aurobindo now has a total of 211 ANDA approvals (183 final approvals including 9 from Aurolife Pharma LLC and 28 tentative approvals) from the USFDA, the company said.