USFDA9 April 2026 at 03:23 am
Glenmark Pharmaceuticals Receives U.S. FDA Approval for Progesterone Vaginal Inserts
AI Summary
Glenmark Pharmaceuticals Limited has received final approval from the U.S. FDA for Progesterone Vaginal Inserts, 100 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug, Endometrin® Vaginal Inserts, 100 mg of Ferring Pharmaceuticals Inc. The product will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA. The Endometrin® Vaginal Inserts, 100 mg market achieved annual sales of approximately $59.2 million as per IQVIA® sales data for the 12-month period ending February 2026.
Key Highlights
- Glenmark Pharmaceuticals received U.S. FDA approval for Progesterone Vaginal Inserts, 100 mg.
- The approved product is bioequivalent and therapeutically equivalent to Endometrin® Vaginal Inserts, 100 mg of Ferring Pharmaceuticals Inc.
- The product will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
- The Endometrin® Vaginal Inserts, 100 mg market achieved annual sales of approximately $59.2 million as per IQVIA® sales data.
- This approval marks an important addition to Glenmark's business and reinforces their focus on addressing patient needs in women’s healthcare.