First Generic Metronidazole Approved by FDA

The FDA has approved the first generic version of Metro-Gel-Vaginal. This vaginal gel is the most effective treatment for bacterial vaginosis, although other pharmaceutical treatments exist. The FDA expects the generic version called Metronidazole Vaginal Gel, 0.75 %, manufactured by QLT USA, Inc., to significantly lower the cost of treating bacterial vaginosis. The recommended dose of metronidazole vaginal gel is 5 grams, applied once daily for 5 days. Metronidazole is also available in an oral form; however, only the vaginal gel received generic approval. Side effects of metronidazole include a metallic taste and nausea.

Bacterial vaginosis is the most common type of vaginal infection, followed by vaginal yeast infection and trichomoniasis. Together, these three types of vaginitis account for about 90 percent of all vaginal infections. The most common symptom associated with bacterial vaginosis is a thin, grayish, vaginal discharge that has a “fishy” or foul odor.

Sources: FDA Press Release; Up to Date, Bacterial Vaginosis, accessed 11/09/06

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