Bacterial Vaginosis :: FDA Approves First Generic Metronidazole

The Food and Drug Administration approved the first generic version of MetroGel-Vaginal (metronidazole vaginal gel), a treatment for bacterial vaginosis. The approval is an important step in the agency’s 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 J. Buehler, Director, and 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 is an antibiotic effective against anaerobic (lacking oxygen) bacteria.

The economic benefits of FDA’s generic drug approval program are significant because generic drug products are used to fill over 50 percent of all prescriptions and can cost a fraction of the price of the brand name drugs. Competition from generic drugs that are safe and effective alternatives may quickly lead to reductions in spending.

The Office of Generic Drugs works expeditiously to review and take action on generic drug applications as quickly as possible. The same thorough and rigorously scientific review standards of safety, efficacy and quality are applied to generic drug applications as are applied to new drug applications. Consumers and health professionals can be assured that an approved generic drug is bioequivalent to the brand name drug and is its equal in dosage form, strength, and route of administration, quality, performance characteristics, and intended use.

Metronidazole Vaginal Gel, 0.75 %, is manufactured by QLT USA, Inc. in Fort Collins, CO. QLT challenged certain patents for the listed drug MetroGel-Vaginal and is eligible for 180 days of generic drug exclusivity. The FDA may approve other applications after the exclusivity period has expired.

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