Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules, 50 milligrams (mg), 100 mg, 200 mg, and 400 mg, held by Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd., Brookhaven, NY 11719 (Amneal). Amneal requested withdrawal of approval of this application and has waived its opportunity for a hearing.

Full Text

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<title>Federal Register, Volume 91 Issue 195 (Friday, October 9, 2026)</title>
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[Federal Register Volume 91, Number 195 (Friday, October 9, 2026)]
[Notices]
[Pages 64658-64659]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20758]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-10396]


Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval 
of Abbreviated New Drug Application for Celecoxib Capsules, 50 
Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of abbreviated new drug application (ANDA) 208833 
for Celecoxib capsules, 50 milligrams (mg), 100 mg, 200 mg, and 400 mg, 
held by Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd., 
Brookhaven, NY 11719 (Amneal). Amneal requested withdrawal of approval 
of this application and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of October 9, 2026.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#f3b89a9e9196819f8addbf969b8195969f97b3959792dd9b9b80dd949c85"><span class="__cf_email__" data-cfemail="387351555a5d4a544116745d504a5e5d545c785e5c591650504b165f574e">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: On May 31, 2018, FDA approved ANDA 208833 
for Celecoxib capsules, 50 mg, 100 mg, 200 mg, and 400 mg. The 
reference listed drug (RLD) is Celebrex (celecoxib) capsules, 50 mg, 
100 mg, 200 mg, and 400 mg, approved under new drug application (NDA) 
020998. According to annual reports filed with the Agency, the drug 
products approved under ANDA 208833 have not been commercially 
manufactured since the ANDA's approval in May 2018.
    In a letter dated September 16, 2021, FDA notified Amneal that it 
had significant concerns about the validity and reliability of 
bioequivalence and bioavailability data generated by a contract 
research organization that had conducted studies relied on by ANDA 
208833 and instructed Amneal to re-conduct bioequivalence studies for 
ANDA 208833 at an alternate site. The September 16, 2021, letter also 
informed Amneal that FDA was changing the therapeutic equivalence 
evaluation code for Amneal's Celecoxib capsules to ``BX.'' \1\ In 
response to multiple inquiries from the Agency, Amneal committed (on 
October 14, 2021, October 6, 2022, and September 18, 2023) to 
submitting new bioequivalence studies to enable FDA to make a full 
evaluation of therapeutic equivalence between Amneal's Celecoxib 
capsules and the RLD.
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    \1\ The code BX is assigned to specific drug products for which 
the data that have been reviewed by the Agency are insufficient to 
determine therapeutic equivalence under the policies stated in the 
``Approved Drug Products with Therapeutic Equivalence Evaluations'' 
(the ``Orange Book'') preface, available at <a href="https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface">https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface</a>. 
Accessed September 16, 2026.
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    On February 22, 2024, FDA requested that Amneal describe its 
efforts to conduct new bioequivalence studies and provide a timeline 
for completing and submitting these studies and requested that Amneal 
agree not to distribute the drug products covered by ANDA 208833 until 
they were shown to be bioequivalent to the RLD based on bioequivalence 
studies conducted at an alternate site. On March 18, 2024, Amneal 
submitted a general correspondence communicating its intent to submit 
new bioequivalence studies by March 2025 and agreeing not to distribute 
the drug products covered by ANDA 208833 until these studies were 
completed and were found to demonstrate bioequivalence to the RLD. In 
November 2024, Amneal's Celecoxib capsules, 50 mg, 100 mg, 200 mg, and 
400 mg, approved under ANDA 208833, were moved to the discontinued 
section of the publication ``Approved Drug Products with Therapeutic 
Equivalence Evaluations'' (known generally as the ``Orange Book'').
    In light of the concerns about the validity and reliability of the 
bioequivalence data on which ANDA 208833 relied for approval, the 
absence of new bioequivalence studies demonstrating the bioequivalence 
of Amneal's Celecoxib capsules to the RLD is a potential problem that 
is sufficiently serious that the drug should be removed from the 
market.
    As of May 28, 2025, Amneal had not submitted new bioequivalence 
studies demonstrating the bioequivalence of its Celecoxib capsules to 
the RLD. Accordingly, FDA suggested that Amneal voluntarily seek 
withdrawal of approval of ANDA 208833 for Celecoxib capsules under 
Sec.  314.150(d) (21 CFR 314.150(d)) and note that it was waiving its 
opportunity for a hearing under Sec.  314.150(a).
    In a request for withdrawal of approval submitted June 6, 2025, as 
amended on June 27, 2025, and July 9, 2025, Amneal requested that FDA 
withdraw approval of ANDA 208833 for Celecoxib capsules under Sec.  
314.150(d) and waived its opportunity for a hearing. Amneal stated that 
its request for withdrawal of approval was based on Amneal's business 
decision.
    For the reasons discussed above, and in accordance with the 
applicant's request, approval of ANDA 208833 for Celecoxib capsules, 50 
mg, 100 mg, 200 mg, and 400 mg, and all amendments and supplements 
thereto, is withdrawn under Sec.  314.150(d). Distribution of Celecoxib 
capsules, 50 mg, 100 mg, 200 mg, and 400 mg, into interstate commerce 
without an approved application is illegal and subject to

[[Page 64659]]

regulatory action (see sections 505(a) and 301(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20758 Filed 10-8-26; 8:45 am]
BILLING CODE 4164-01-P


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