East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Ezetimibe Tablets USP, 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Ezetimibe Tablets USP, 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug ZETIA®.
Ezetimibe is indicated as adjunctive therapy for the reduction of elevated total cholesterol.
The product has an estimated market size of $2.3B for the twelve months ending July 2017 according to IMS*.
Ezetimibe Tablets USP, 10 mg. represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 278 final approvals, including 38 tentative approvals, and 16 approved products from Aurolife. There are 104 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT April 2017