Glenmark receives US FDA approval for Progesterone Vaginal Inserts, 100 mg

Glenmark Pharmaceuticals has received final approval from the United States Food & Drug Administration (US 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 US by Glenmark Pharmaceuticals Inc., USA.

Commenting on the launch, Marc Kikuchi, President & Business Head, North America said, “At Glenmark, we remain focused on expanding access to quality and affordable medicines while continuing to strengthen our portfolio in the U.S. This approval for Progesterone Vaginal Inserts, 100 mg marks an important addition to our business and reinforces our focus on addressing patient needs in women’s healthcare.”