FDA OKs GENERIC METRONIDAZOLE GEL

Pharmacy Times, Volume 0, 0

The FDA gave marketing approval for the first generic versionof MetroGel-Vaginal (metronidazole vaginal gel), callingthe action "an important step in the agency's effort toincrease the availability of lower-cost generic medications."The new generic, a treatment for bacterial vaginosis causedby an overgrowth of bacteria in the vagina, will be manufacturedby Fort Collins, Colo-basedQLT USA Inc, under the FDA's 180-day exclusivity rule.

"This approval is another exampleof our agency's efforts toincrease access to safe and effectivegeneric versions of approvedbrand 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 antibacterialpreparation, and its generic version can bring significant savingsto the millions of Americans with bacterial vaginosis."