FDA OKs GENERIC METRONIDAZOLE GEL

DECEMBER 01, 2006

The FDA gave marketing approval for the first generic version of MetroGel-Vaginal (metronidazole vaginal gel), calling the action "an important step in the agency's effort to increase the availability of lower-cost generic medications." The new generic, a treatment for bacterial vaginosis caused by an overgrowth of bacteria in the vagina, will be manufactured by Fort Collins, Colo-based QLT USA Inc, under the FDA's 180-day exclusivity rule.

"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, 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."




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