FDA Clears Path for Generic Chewable Tadalafil Tablets
Published Date: 4/16/2026
Notice
Summary
The FDA has decided that CHEWTADZY chewable tablets (5 mg, 10 mg, 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.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Generics Can Be Approved Now
The FDA determined that CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. Because of this determination, abbreviated new drug applications (ANDAs) that refer to NDA 218527 (CHEWTADZY, initially approved June 28, 2024) may be approved if they meet all other legal and regulatory requirements.
Product Remains Listed as Discontinued
FDA will continue to show CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, 20 mg, in the Orange Book’s “Discontinued Drug Product List,” which identifies products discontinued from marketing for reasons other than safety or effectiveness. The listing will remain in place while ANDAs referencing the product can still be approved if they meet requirements.
Labeling Updates May Be Requested
FDA said that if it determines the labeling for CHEWTADZY (tadalafil) chewable tablets should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. ANDA applicants should be prepared to provide updated labeling if FDA requests it.
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