2025-06053Notice

VIBRAMYCIN Oral Suspension Gets FDA Safety Seal of Approval

Published Date: 4/9/2025

Notice

Summary

The FDA says VIBRAMYCIN oral suspension (25 mg/5 mL) wasn’t pulled from 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 hikes. If you rely on this medicine, good news—it’s here to stay!

Analyzed Economic Effects

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

Generic Approvals Continue for VIBRAMYCIN

The FDA determined that VIBRAMYCIN (doxycycline) oral suspension, equivalent 25 mg base/5 mL, was not withdrawn from sale for reasons of safety or effectiveness. Because of that determination, the FDA will not begin procedures to withdraw approvals of abbreviated new drug applications (ANDAs) that refer to this product and can continue to approve ANDAs that refer to it if they meet legal and regulatory requirements.

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Key Dates

Published Date
4/9/2025

Department and Agencies

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