FDA Approves Glenmark Pharmaceuticals Generic MetroGel

The drug is used to treat bacterial vaginosis and is a generic version of Bausch Health US LLC’s MetroGel-Vaginal.

The US Food & Drug Administration (FDA) granted final approval to Glenmark Pharmaceuticals (Glenmark) on Friday for its metronidazole topical gel as a generic version of Bausch Health US LLC’s MetroGel-Vaginal.1

According to IQVIA sales data for the 12-month period ending in November 2021, MetroGel-Vaginal reported annual sales of approximately $60.4 million.

The global pharmaceutical company’s key therapeutic areas of focus include respiratory, dermatology, and oncology.

Glenmark’s new product adds to the firm’s growing portfolio of 173 products authorized for US distribution, with an additional 46 abbreviated new drug applications pending FDA approval.

This article originally appeared on Contemporary Ob/Gyn.

Reference

  1. Glenmark Pharmaceuticals Receives ANDA Approval for Metronidazole Vaginal Gel, 0.75%. News release. January 28, 2022. Accessed January 31, 2022. https://www.glenmarkpharma.com/sites/default/files/Glenmark-receives-ANDA-approval-for-Metronidazole-Vaginal-Gel-0-75%25_0.pdf