FDA APPROVES QLT'S GENERIC METRONIDAZOLE

The FDA has approved the first generic version of MetroGel-Vaginal (metronidazole gel), a treatment for bacterial vaginosis. The approval part of the FDA's effort to increase the availability of lower-cost generic medications, the agency said.

"Metronidazole vaginal gel is a widely used antibacterial preparation, and its generic version can bring significant savings to the millions of Americans with bacterial vaginosis," Gary Buehler, director of the Office of Generic Drugs, said. Metronidazole is an antibiotic effective against anaerobic bacteria.

The generic metronidazole is manufactured by QLT. MetroGel-Vaginal is manufactured by 3M. QLT challenged certain patents on the brand drug and is eligible for 180 days of generic drug exclusivity. The FDA may approve other applications after the exclusivity period has expired.