FDA: That sulfa pill wasn't yanked for being bunk
Published Date: 9/29/2026
Notice
Summary
The FDA has decided that the 500 mg sulfadiazine tablet wasn’t taken off the market because it was unsafe or didn’t work. This means generic drug makers can now apply to sell their 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
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Generic Makers Can Seek Approval Now
The FDA determined that SULFADIAZINE (sulfadiazine) tablet, 500 mg, was not withdrawn from sale for reasons of safety or effectiveness. Because of that determination, abbreviated new drug applications (ANDAs) that refer to this listed drug may be approved if they meet all other legal and regulatory requirements; the drug was moved to the Orange Book "Discontinued Drug Product List" after Eli Lilly notified FDA of discontinuation on May 16, 1996, and the citizen petition prompting this determination was submitted on February 4, 2025. This may allow generic companies to seek approval and could lead to more affordable options for patients and pharmacies.
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