2025-06783Notice

FDA Says MOBIC Tablets Are Fine, Generics Keep Flowing Smoothly

Published Date: 4/21/2025

Notice

Summary

The FDA says MOBIC tablets (7.5 mg and 15 mg) weren’t taken off the market because of safety or effectiveness problems. This means generic versions can keep getting approved, so patients and pharmacies won’t face shortages or price jumps. If you use or sell MOBIC, things will keep running smoothly with no surprise changes.

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Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

Generic MOBIC Approvals Continue

The FDA determined that MOBIC (meloxicam) tablets, 7.5 mg and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. Because of that finding, the FDA will not start procedures to withdraw approvals of abbreviated new drug applications (ANDAs) that refer to these products and will continue to approve ANDAs that refer to them if they meet legal and regulatory requirements. This lets the FDA keep approving generic versions, helping patients and pharmacies avoid shortages or sudden price increases.

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Key Dates

Published Date
4/21/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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