FDA Clears Generic Path for Disintegrating Pepcid Tablets
Published Date: 10/27/2026
Notice
Summary
The FDA has confirmed that PEPCID RPD (famotidine) orally disintegrating tablets, 20 mg and 40 mg, were not taken off the market because of safety or effectiveness problems. This means generic drug makers can now apply to sell their versions, speeding up access and potentially lowering costs for patients. If all rules are met, these generics could hit the shelves soon, helping folks who rely on this heartburn relief.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Generics Can Be Approved for Famotidine ODT
The FDA determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 mg and 40 mg, were not withdrawn for reasons of safety or effectiveness. Because of that determination, the Agency may approve abbreviated new drug applications (ANDAs) that refer to this listed drug (NDA 020752) if the applicants meet all other legal and regulatory requirements.
Patients May Get Cheaper, Faster Access
You could get faster access and potentially lower costs for PEPCID RPD (famotidine) orally disintegrating tablets, 20 mg and 40 mg, because FDA found they were not withdrawn for safety or effectiveness and therefore ANDAs for generics may be approved. The citizen petition was submitted June 29, 2026, and FDA announced this determination in the Federal Register on October 27, 2026.
Applicants May Need Updated Labeling
If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit updated labeling for PEPCID RPD (famotidine) orally disintegrating tablets, 20 mg and 40 mg. This is an additional step ANDA applicants may need to follow during the approval process.
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