FDA Officially Declares DEMEROL Still Safe After All
Published Date: 12/12/2025
Notice
Summary
The FDA has decided that DEMEROL 100 mg tablets and some other drugs weren’t taken off the market because they’re unsafe or don’t work. This means generic drug makers can keep getting approval to sell their versions, as long as they follow the rules. Patients and pharmacies can expect these meds to stay available without any surprise price hikes or shortages.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Generic Approvals Remain Allowed
In a December 12, 2025 notice, FDA found that DEMEROL (meperidine hydrochloride) 100 mg tablets and the other listed products were not withdrawn from sale for reasons of safety or effectiveness. That means FDA will not start proceedings to withdraw ANDA approvals that refer to those drugs, approved ANDAs that refer to them remain unaffected, and the Agency may continue to approve additional ANDAs that refer to those products if they meet legal and regulatory requirements.
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Key Dates
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