Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—NOTICES: Flagyl (metronidazole) tablets were not withdrawn from sale for reasons of safety, effectiveness, (Sep 6, 2024)

By WK Editorial Staff

If the FDA determines that labeling for these drug products should be revised to meet current standards, the FDA will advise ANDA applicants to submit such labeling.

The FDA has determined that flagyl (metronidazole) tablets, 250 milligrams (mg) and 500 mg, were not withdrawn from sale for reasons of safety or effectiveness. Flagyl is indicated for treatment of symptomatic Trichomoniasis, asymptomatic Trichomoniasis, treatment of asymptomatic sexual partners, Amebiasis, anaerobic bacterial infections among other infections, as listed on the product label, and as clinically indicated for treatment. The determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements. (Notice, 89 Fed. Reg. 71907 (Sept. 4, 2024)).

Dates. August 28, 2024.

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