Dayton, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Eszopiclone Tablets USP, 1 mg, 2 mg, and 3 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limitedís Eszopiclone Tablets USP, 1 mg, 2 mg, and 3 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD),
LUNESTAÆ manufactured by Sunovion.
Eszopiclone Tablets USP, 1 mg, 2 mg, and 3 mg is indicated for the treatment of insomnia.
The product has an estimated market size of $78.8M for the twelve months ending August 2016 according to IMS*.
Eszopiclone Tablets USP, 1 mg, 2 mg, and 3 mg represents the latest addition to Aurobindoís broad line of vertically integrated pharmaceuticals. Aurobindoís product portfolio consists of 232 final approvals, including 38 tentative approvals and 13 from Aurolife Pharma LLC. There are 166 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT August 2016