FDA approves generic metronidazole

WASHINGTON, Nov. 1 (UPI) -- The U.S. Food and Drug Administration has approved the first generic version of MetroGel-Vaginal (metronidazole), a treatment for bacterial vaginosis.

The agency said its Wednesday action is an important step in its effort to increase the availability of lower-cost generic medications.

Bacterial vaginosis is a condition in women that is characterized by vaginal discharge and results from an overgrowth of bacteria in the vagina.

"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 Buehler, director of the FDA's Office of Generic Drugs. "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."

Metronidazole Vaginal Gel is manufactured by QLT USA Inc. in Fort Collins, Colo. The company is eligible for 180 days of generic drug exclusivity. The FDA said it may approve other applications after the exclusivity period has expired.