Glenmark Pharmaceuticals bags FDA approval for Metronidazole Vaginal Gel

Glenmark Pharmaceuticals said that it has bagged final approval from the US States Food and Drug Administration (FDA) for Metronidazole Vaginal Gel, 0.75%, which is the generic for MetroGel-Vaginal Gel, 0.75% owned by Bausch Health US.

As per IQVIA sales data for the 12-month period ending November 2021, the MetroGelVaginal Gel, 0.75% market recorded annual sales of around $60.4 million.

The current portfolio of Glenmark Pharmaceuticals has 173 products approved for distribution in the US marketplace and 46 ANDA’s pending approval with the FDA.

Earlier this month, the Indian pharma company was granted tentative approval from the FDA for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe.