Federal Register #FDA2025P4154

FDA determination on CHEWTADZY (Tadalafil) Chewable Tablets and ANDA eligibility

This notice from the Food and Drug Administration (FDA) addresses the regulatory status of CHEWTADZY (tadalafil) chewable tablets: - Government Buyer: - Food and Drug Administration (FDA), Center for Drug Evaluation and Research - OEM and Vendor Information: - OEM: B Better, LLC (holder of New Drug Application NDA 218527 for CHEWTADZY) - Products/Services Requested: - CHEWTADZY (tadalafil) chewable tablets in 5 mg, 10 mg, and 20 mg strengths - Indicated for erectile dysfunction and benign prostatic hyperplasia - No specific quantities or procurement actions requested - Pharmacy Compounding Advisory Committee Meeting (regulatory advisory service, not a procurement) - Unique or Notable Requirements: - FDA determined CHEWTADZY was not withdrawn for safety or effectiveness reasons - Enables FDA approval of abbreviated new drug applications (ANDAs) for generic versions - CHEWTADZY remains listed in the Orange Book's Discontinued Drug Product List - No purchase or acquisition of products/services is solicited in this notice - Place of Performance and Related Locations: - FDA White Oak Campus, Silver Spring, MD (advisory committee meeting) - FDA headquarters, Silver Spring, MD (contracting office) - No estimated contract value, product/service quantities, or procurement actions are associated with this notice.

Description

The Food and Drug Administration (FDA) has determined that CHEWTADZY (tadalafil) chewable tablets in 5 mg, 10 mg, and 20 mg strengths were not withdrawn from sale for reasons of safety or effectiveness. This determination allows the FDA to approve abbreviated new drug applications (ANDAs) for these tablets if all other legal and regulatory requirements are met. The drug, initially approved in 2024, has never been marketed, but the FDA's review found no evidence of withdrawal due to safety or effectiveness concerns. The drug will remain listed in the Discontinued Drug Product List section of the Orange Book, enabling generic versions to be approved.

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