East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Moxifloxacin Ophthalmic Soln. 0.5%. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Moxifloxacin Ophthalmic Soln. 0.5%. to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Vigamox®
Moxifloxacin Ophthalmic Solution is indicated as a topical ophthalmic fluoroquinolone anti-infective.
The product has an estimated market size of $248.7M for the twelve months ending August 2017 according to IMS*.
Moxifloxacin Ophthalmic Soln. 0.5% represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 278 final approvals, including 39 tentative approvals, and 16 approved products from Aurolife. There are 119 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT August 2017