Determination That CHEWTADZY (Tadalafil) Chewable Tablets, 5 Milligrams, 10 Milligrams, 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)]
[Notices]
[Pages 20464-20465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-07443]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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Milligrams, 10 Milligrams, 20 Milligrams, Were Not Withdrawn From Sale 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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(mg), 10 mg, 20 mg, were not withdrawn from sale for reasons of safety 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 (Sec.  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 Sec. Sec.  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 Sec.  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

[[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