From USFDA
Aurobindo Pharma announced that the Company has received the final approval from the US Food and Drug Administration (FDA) to manufacture and market Telmisartan Tablets USP 20 mg, 40 mg and 80 mg (ANDA 206511). The Telmisartan Tablets are indicated in the treatment of essential hypertension and has an estimated market size of USD 92 million for the twelve months ending July 2015 according to IMS.The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Micardis Tablets of Boehringer Ingelheim Pharmaceuticals, Inc.
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