Generic Metronidazole Gets FDA Approval
The first generic version of MetroGel-Vaginal (metronidazole vaginal gel) has been approved by the U.S. Food and Drug Administration to treat bacterial vaginosis, the agency said Wednesday.
The condition, caused by an overgrowth of vaginal bacteria, may be accompanied by symptoms including discharge, odor, pain, itching or burning, the U.S. Centers for Disease Control and Prevention (CDC) says. It's the most common vaginal infection among women of childbearing age.
MetroGel-Vaginal is produced by 3M Co.; license to produce the generic equivalent was granted to Colorado-based QLT USA Inc.
Generic drugs, now used to fill more than 50 percent of all prescriptions, can cost a fraction of the price of their brand-name equivalents, the FDA said. "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," the agency said.
Metronidazole is used extensively to treat rosacea.
The condition, caused by an overgrowth of vaginal bacteria, may be accompanied by symptoms including discharge, odor, pain, itching or burning, the U.S. Centers for Disease Control and Prevention (CDC) says. It's the most common vaginal infection among women of childbearing age.
MetroGel-Vaginal is produced by 3M Co.; license to produce the generic equivalent was granted to Colorado-based QLT USA Inc.
Generic drugs, now used to fill more than 50 percent of all prescriptions, can cost a fraction of the price of their brand-name equivalents, the FDA said. "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," the agency said.
Metronidazole is used extensively to treat rosacea.
posted by Madison at 10:35 AM
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