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The FDA determined that TOLECTIN DS (tolmetin sodium) capsule, equivalent to 400 mg base, was not withdrawn for reasons of safety or effectiveness.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 The original NDA was approved October 30, 1979, and its approval was withdrawn effective July 8, 2011; the citizen petition was filed September 5, 2025, and the FDA determination was published February 18, 2026.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Because the FDA found TOLECTIN DS (tolmetin sodium) capsule, equivalent to 400 mg base, was not withdrawn for safety or effectiveness, generic companies may seek ANDA approval for this product.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.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-06478 — Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY
The FDA has officially set the review period for VYLOY, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind VYLOY, giving them a chance to extend their patent protection and potentially boost profits. If anyone thinks the dates are wrong or wants to challenge the company’s review speed, they must act by June 2 or September 30, 2026.
2026-06481 — Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI
The FDA has set the official review period for HYMPAVZI, a new human biological product, so its patent holder can apply for extra patent time. This affects the company behind HYMPAVZI and anyone interested in patent extensions. If you think the dates are wrong or want to challenge the company’s diligence, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.
2026-06480 — Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
The FDA has officially set the review period for EMRELIS, a medicine patent, so the patent owner can apply for extra protection time. If anyone thinks the dates are wrong, they have until June 2, 2026, to speak up. Also, people can challenge whether the patent owner was diligent during the review by September 30, 2026. This affects patent holders and could impact how long they keep exclusive rights to their product.
2026-06479 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA
The FDA has set the official review period for ENFLONSIA, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind ENFLONSIA and anyone interested in patent rules. If you think the dates are wrong or want to challenge the company’s review speed, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.
2026-06477 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO
The FDA has officially set the review period for ENCELTO, a medicine patent, so the company can apply to extend its patent protection. This affects the drug maker by potentially giving them more time to exclusively sell ENCELTO, which can mean more money. If anyone thinks the dates are wrong or the company wasn’t diligent, they have until June 2 or September 30, 2026, to speak up.
2026-06483 — Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER
The FDA has officially set the review period for INJECTAFER, a drug patent up for extension. This means the company can apply to extend their patent protection, potentially keeping their exclusive rights longer and impacting competition and pricing. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by June 2 or September 30, 2026.
Previous / Next Documents
Previous: 2026-03212 — Agency Information Collection Activities; Proposed eCollection eComments Requested; Reinstatement With Change of a Previously Approved Collection; Office for Victims of Crime Training and Technical Assistance Center (OVC TTAC) Feedback Form Package
The Department of Justice wants to bring back and update a feedback form used by the Office for Victims of Crime Training and Technical Assistance Center. This change aims to make it easier and quicker for people to share their thoughts, using more electronic options. Anyone who uses or benefits from OVC TTAC services can comment until April 20, 2026, helping shape how the form works without adding extra hassle or cost.
Next: 2026-03214 — Proposed Collection; 60-Day Comment Request; Chimpanzee Research Use Form (Office of the Director)
The NIH wants to keep using a form that helps them check if chimpanzee research follows their rules. They’re asking the public to share thoughts by April 20, 2026, to make sure the form is useful and not too much work. This won’t cost extra money but helps keep research safe and fair for chimps and scientists alike.
Take It Personal
Get Your Personalized Policy View
Start a Free Government Policy Watch to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in