FDA Says Old Pain Pill Safe Enough for Generic Comeback
Published Date: 2/18/2026
Notice
Summary
The FDA has decided that TOLECTIN DS (tolmetin sodium) 400 mg capsules weren’t taken off the market because of safety or effectiveness problems. This means generic drug makers can now apply to sell their own versions, as long as they meet all the rules. Patients and pharmacies could see more affordable options soon, with no safety worries holding things back!
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Generic Makers Can Seek Approval
The FDA determined that TOLECTIN DS (tolmetin sodium) capsule, equivalent to 400 mg base, was not withdrawn for reasons of safety or effectiveness. Because of that finding, abbreviated new drug applications (ANDAs) that refer to this listed drug (NDA 018084) may be approved if they meet all other legal and regulatory requirements. The original NDA was approved October 30, 1979, and its approval was withdrawn effective July 8, 2011; the citizen petition was filed September 5, 2025, and the FDA determination was published February 18, 2026.
Potential Lower-Cost Tolmetin Options
Because the FDA found TOLECTIN DS (tolmetin sodium) capsule, equivalent to 400 mg base, was not withdrawn for safety or effectiveness, generic companies may seek ANDA approval for this product. That could lead to additional generic versions becoming available and may provide more affordable options for patients and pharmacies if ANDAs are approved and products reach the market.
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Key Dates
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