Aurobindo’s hypertension and diabetes generics earn FDA approval

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Aurobindo’s hypertension and diabetes generics earn FDA approval

By Brian Berk - 05/22/2017

EAST WINDSOR, N.J. — The Food and Drug Administration granted final approval for Aurobindo Pharma’s amlodipine and olmesartan medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. The Division of Bioequivalence has determined Aurobindo's Amlodipine and olmesartan medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Azor of Daiichi Sankyo.


Amlodipine and olmesartan medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg is indicated in for the treatment of hypertension. The product has an estimated market size of $255.8M for the twelve months ending March 2017 according to IMS. 


Aurobindo also received final approval from the FDA for Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg. The Division of Bioequivalence has determined Aurobindo's Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Glucotrol XL Tablets, of Pfizer.


Glipizide Extended-Release Tablets, 2.5 mg, 5 mg and 10 mg is indicated in for the treatment of diabetes.


The product has an estimated market size of $70.3M for the twelve months ending March 2017 according to IMS


According to Aurobindo, its product portfolio consists of 262 final approvals, including 36 tentative approvals, and 16 approved products from Aurolife. There are 104 additional products on file with FDA.


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