Glenmark Pharmaceuticals (Glenmark) has received final approval from the United States Food & Drug Administration (U.S. FDA) for Progesterone Vaginal Inserts, 100 mg, determined by the FDA to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Endometrin® Vaginal Inserts, 100 mg of Ferring Pharmaceuticals Inc. [NDA 022057].

Glenmark's Progesterone Vaginal Inserts, 100 mg will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.