Saptalis Announces FDA Approval of Metronidazole Vaginal Gel, 0.75%

Saptalis Pharmaceuticals, LLC is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Metronidazole Vaginal Gel, 0.75%. Saptalis’ product is therapeutically equivalent to the Reference Listed Drug (RLD), Metrogel-Vaginal® 0.75%, marketed by Bausch Health. Metronidazole vaginal gel is indicated for the treatment of bacterial vaginosis. The product will be available in 70-gram tubes, each packaged with five vaginal applicators. According to the latest estimates from IQVIA/IMS Health, the current annual U.S. market for Metronidazole Vaginal Gel, 0.75% is approximately $34 million, with 1.7 million units sold annually. Saptalis’ Metronidazole Vaginal Gel is manufactured at its facility in Hauppauge, NY, and is expected to launch in the coming weeks.

The release as fetched from its publisher. saptalis.com ↗