East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Lorazepam Tablets USP, 0.5 mg, 1 mg, and 2 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Lorazepam Tablets USP to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Ativan®.
Lorazepam tablets are indicated for the management of anxiety disorders.
The product has an estimated market size of $108M for the twelve months ending October 2017 according to IMS*.
Lorazepam Tablets USP represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 286 final approvals, including 36 tentative approvals, and 17 approved products from Aurolife. There are 115 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT October 2017