FDA Approves First Generic Version of Metronidazole
The bacterial vaginosis treatment is widely used, so large savings are expected
THURSDAY, Nov. 2 (HealthDay News) -- The U.S. Food and Drug Administration has granted approval for the first generic version of MetroGel-Vaginal, an antibiotic effective against anaerobic bacteria and used to treat bacterial vaginosis.
The manufacturer of Metronidazole Vaginal Gel, 0.75 percent, is QLT USA, Inc., of Fort Collins, Colo. The company has 180 days' exclusivity for the drug. The FDA noted that the approval of generic drugs can help keep medical costs down.
"This approval is another example of our agency's efforts to increase access to safe and effective generic versions of approved brand-name drugs as soon as the law permits," said Gary J. Buehler, R.Ph., director of the FDA's Office of Generic Drugs, in a statement. "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," he added.