Determination That CHEWTADZY (Tadalafil) Chewable Tablets Were Not Withdrawn From Sale for Safety or Effectiveness

Notice

Determination That CHEWTADZY (Tadalafil) Chewable Tablets, 5 Milligrams, 10 Milligrams, 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

A Notice by the Food and Drug Administration on 04/16/2026

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• Public Inspection Published Document: 2026-07443 (91 FR 20464) Document Headings ###### Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2025-P-4154]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) has determined that CHEWTADZY (tadalafil) chewable tablets, 5 milligrams (mg), 10 mg, 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tadalafil, chewable tablets, 5 mg, 10 mg, 20 mg, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:

Neerja Razdan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, (240) 402-1556, Neerja.Razdan@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, 20 mg, is the subject of NDA 218527, held by B Better, LLC, and initially approved on June 28, 2024. CHEWTADZY is indicated for the treatment of erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia, and erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia.

B Better, LLC has never marketed CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, 20 mg. In previous instances (see, e.g., 72 FR 9763 (March 5, 2007), 61 FR 25497 (May 21, 1996)), the Agency has determined that, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale.

Hyman, Phelps & McNamara, P.C. submitted a citizen petition dated September 22, 2025 (Docket No. FDA-2025-P-4154), under 21 CFR 10.30, requesting that the Agency determine whether CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, 20 mg, were withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, 20 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, 20 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, 20 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have ( printed page 20465) reviewed the available evidence and determined that these drug products were not withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, 20 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, 20 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2026-07443 Filed 4-15-26; 8:45 am]

BILLING CODE 4164-01-P

Published Document: 2026-07443 (91 FR 20464)