FDA Clears Vintage Ear Drops for Continued Sale
Published Date: 5/9/2025
Notice
Summary
The FDA checked and confirmed that certain drugs, like VOSOL 2% Otic Solution, weren’t taken off the market because they’re unsafe or don’t work. This means these drugs can keep being sold, and new versions can still get approved if they follow the rules. If you’re a drug maker or user, no sudden changes or costs are coming your way right now!
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Listed Drugs Remain Approved
You can keep buying the listed drug products because the FDA found they were not withdrawn from sale for reasons of safety or effectiveness. The FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these products, so the products can continue to be sold.
Generics Can Still Be Approved
If you make generic drugs, the FDA will continue approving abbreviated new drug applications (ANDAs) that refer to these listed products as long as the applications meet legal and regulatory requirements. The FDA also will not begin procedures to withdraw approvals of ANDAs that refer to these products.
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