Glenmark Receives U.S. FDA Approval for Progesterone Vaginal Inserts, 100 mg
Glenmark Pharmaceuticals Limited has secured final approval from the United States Food & Drug Administration (U.S. FDA) for Progesterone Vaginal Inserts, 100 mg. The FDA determined that the product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Endometrin® Vaginal Inserts, 100 mg, manufactured by Ferring Pharmaceuticals Inc. (NDA 022057). Glenmark's Progesterone Vaginal Inserts, 100 mg will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.Marc Kikuchi, President & Business Head, North America, commented on the launch, stating that the approval for Progesterone Vaginal Inserts, 100 mg, marks an important...