Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportunity for a Hearing

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Published

December 29, 2025

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three abbreviated new drug applications (ANDAs) and is announcing an opportunity for the ANDA holders to request a hearing on this proposal. The basis for the proposal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs.

Full Text

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<title>Federal Register, Volume 90 Issue 245 (Monday, December 29, 2025)</title>
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[Federal Register Volume 90, Number 245 (Monday, December 29, 2025)]
[Notices]
[Pages 60724-60726]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23870]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-N-4684]

Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw
Approval of Three Abbreviated New Drug Applications; Opportunity for a
Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is proposing to withdraw approval
of three abbreviated new drug applications (ANDAs) and is announcing an
opportunity for the ANDA holders to request a hearing on this proposal.
The basis for the proposal is that these ANDA holders have repeatedly
failed to file required annual reports for those ANDAs.

DATES: The ANDA holder may submit a request for a hearing by January
28, 2026. Submit all data, information, and analyses upon which the
request for a hearing relies February 27, 2026. Submit electronic or
written comments by February 27, 2026.

ADDRESSES: The request for a hearing may be submitted by the ANDA
holder by either of the following methods:

Electronic Submissions

Written/Paper Submissions

Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> Because your request for a hearing will be made public,
you are solely responsible for ensuring that your request does not
include any confidential information that you or a third party may not
wish to be posted, such as medical information, your or anyone else's
Social Security number, or confidential business information, such as a
manufacturing process. The request for a hearing must include the
Docket No. FDA-2025-N-4684 for ``Egis Pharmaceuticals Limited, et al.;
Proposal to Withdraw Approval of Three Abbreviated New Drug
Applications; Opportunity for a Hearing.'' The request for a hearing
will be placed in the docket and publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday. The ANDA holders may submit all data
and analyses upon which the request for a hearing relies in the same
manner as the request for a hearing except as follows:
<bullet> Confidential Submissions--To submit any data analyses with
confidential information that you do not wish to be made publicly
available, submit your data and analyses only as a written/paper
submission. You should submit two copies total of all data and
analyses. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy,
including the claimed confidential information, in its consideration of
any decisions on this matter. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>
or available at the Dockets Management Staff between 9 a.m. and 4 p.m.,
Monday through Friday. Submit both copies to the Dockets Management
Staff. Any information marked as ``confidential'' will not be disclosed

[[Page 60725]]

except in accordance with 21 CFR 10.20 and other applicable disclosure
law.
Comments Submitted by Other Interested Parties: For all comments
submitted by other interested parties, submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-N-4684 for ``Egis Pharmaceuticals Limited, et.al.; Proposal to
Withdraw Approval of Three Abbreviated New Drug Applications;
Opportunity for a Hearing.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-
796-3471, <a href="/cdn-cgi/l/email-protection#abe6cad9dfc3ca85e5ccded2cec5ebcdcfca85c3c3d885ccc4dd"><span class="__cf_email__" data-cfemail="5c113d2e28343d72123b292539321c3a383d7234342f723b332a">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: The holder of an approved ANDA to market a
new drug for human use is required to submit annual reports to FDA
concerning its approved ANDA under Sec. Sec. 314.81 and 314.98 (21 CFR
314.81 and 21 CFR 314.98). The holders of the approved ANDAs listed in
table 1 have repeatedly failed to submit the required annual reports
and have not responded to the Agency's request for submission of the
reports.

Table 1--Approved ANDAs for Which Required Reports Have Not Been
Submitted
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Application No. Drug Applicant
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ANDA 060453................ Bacitracin-neomycin Ambix
sulfate-polymyxin B Laboratories, 55
sulfate ointment with West End Rd.,
diperodon Totowa, NJ 07512.
hydrochloride (HCl).
ANDA 074748................ Captopril tablet, 12.5 Egis
mg, 25 mg, 50 mg, and Pharmaceuticals
100 mg. Ltd., 1475
Budapest 10 Pf.
100 HUNGARY.
ANDA 074808................ Piroxicam capsule, 10 Do.
mg and 20 mg.
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Therefore, under Sec. Sec. 314.150(b)(1) and 314.200, notice is
given to the holders of the approved ANDAs listed in table 1 and to all
other interested persons that the Director of CDER proposes to issue an
order, under section 505(e) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)), withdrawing approval of the ANDAs and
all amendments and supplements thereto on the grounds that the ANDA
holders have failed to submit reports required under Sec. 314.81 and
314.98.
In accordance with section 505 of the FD&C Act and part 314 (21 CFR
part 314), the ANDA holders are hereby provided an opportunity for a
hearing to show why the approval of the ANDA listed previously should
not be withdrawn and an opportunity to raise, for administrative
determination, all issues relating to the legal status of the drug
products covered by these ANDAs.
An ANDA holder who decides to seek a hearing must file the
following: (1) A written notice of participation and request for a
hearing (see DATES and ADDRESSES) and (2) the data, information, and
analyses relied on to demonstrate that there is a genuine and
substantial issue of fact that requires a hearing (see DATES and
ADDRESSES). Any

[[Page 60726]]

other interested person may also submit comments on this notice. The
procedures and requirements governing this notice of opportunity for a
hearing, notice of participation and request for a hearing, the
information, and analyses to justify a hearing, other comments, and a
grant or denial of a hearing are contained in Sec. 314.200 and in 21
CFR part 12.
The failure of an ANDA holder to file a timely written notice of
participation and request for a hearing, as required by Sec. 314.200,
constitutes an election by that ANDA holder not to avail itself of the
opportunity for a hearing concerning CDER's proposal to withdraw
approval of the ANDAs and constitutes a waiver of any contentions
concerning the legal status of the drug products. FDA will then
withdraw approval of the ANDAs, and the drug products may not
thereafter be lawfully introduced or delivered for introduction into
interstate commerce. Any new drug product introduced or delivered for
introduction into interstate commerce without an approved ANDA is
subject to regulatory action at any time.
A request for a hearing may not rest upon mere allegations or
denials but must present specific facts showing that there is a genuine
and substantial issue of fact that requires a hearing. If a request for
a hearing is not complete or is not supported, the Commissioner of Food
and Drugs will enter summary judgment against the person who requests
the hearing, making findings and conclusions, and denying a hearing.
All submissions under this notice of opportunity for a hearing must
be filed in two copies. Except for data and information prohibited from
public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the
submissions may be seen at the Dockets Management Staff (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
This notice is issued under section 505(e) of the FD&C Act and
under authority delegated to the Director of CDER by the Commissioner
of Food and Drugs.

Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-23870 Filed 12-23-25; 8:45 am]
BILLING CODE 4164-01-P

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