FDA Greenlights Generics for Chewable Tadalafil Tablets
Published Date: 4/16/2026
Notice
Summary
The FDA has decided that CHEWTADZY chewable tablets (5, 10, and 20 mg) were not taken off the market because of safety or effectiveness problems. This means generic versions can now get approved if they meet all the rules. Patients and drug makers can expect more affordable options soon, with no safety worries holding things back.
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Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Generic Approval Pathway Opens
The FDA has officially found that CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, and 20 mg, were not withdrawn from sale for safety or effectiveness. Because of that finding, abbreviated new drug applications (ANDAs) that refer to that listed drug (NDA 218527, held by B Better, LLC, initially approved June 28, 2024) may be approved if they meet all other legal and regulatory requirements. This decision was published in the Federal Register on April 16, 2026.
Possible Labeling Revision Requirement
The FDA said that if it determines labeling for CHEWTADZY should be updated to meet current standards, the Agency will advise ANDA applicants to submit revised labeling. That means companies seeking to make a generic may need to change their product labeling to match FDA guidance before approval.
FDA Found No Safety-Based Withdrawal
After reviewing the citizen petition (filed September 22, 2025), agency records, and postmarketing data, FDA determined CHEWTADZY chewable tadalafil tablets (5 mg, 10 mg, 20 mg) were not withdrawn for reasons of safety or effectiveness. The Agency reviewed the evidence and will continue to list the product in the Orange Book's Discontinued Drug Product List as discontinued for reasons other than safety or effectiveness.
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