Glenmark gets nod from US FDA for generic drug

Glenmark Pharmaceuticals said its US-based unit has received approval from the US health regulator to market Metronidazole Vaginal gel, in the American market.

The drug firm has received final approval by the US Food and Drug Administration (FDA) for its product which is a generic version of Bausch Health US LLC’s MetroGel-Vaginal, the drug firm said in a statement.

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

Glenmark’s current portfolio consists of 173 products authorised for distribution in the US marketplace and 46 ANDAs are pending approval with the FDA.