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."