[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64936-64938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17515]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3271]
Flamingo Pharmaceuticals Ltd.; Proposal To Withdraw Approval of
Two Abbreviated New Drug Applications; Opportunity for a Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is proposing to withdraw approval
of two abbreviated new drug applications (ANDAs) and is announcing an
opportunity for the ANDA holder to request a hearing on this proposal.
The basis for the proposal is that the ANDA holder has repeatedly
failed to file required annual reports for those ANDAs.
DATES: The ANDA holder may submit a request for a hearing by September
9, 2024. Submit all data, information, and analyses upon which the
request for a hearing relies October 7, 2024. Submit electronic or
written comments by October 7, 2024.
ADDRESSES: The request for a hearing may be submitted by the ANDA
holder by either of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments to submit your request
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a
hearing, will be posted to the docket unchanged.
Written/Paper Submissions
Submit written/paper submissions as follows:
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.
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-2024-N-3271 for ``Flamingo Pharmaceuticals Ltd.;
Proposal To Withdraw Approval of Two Abbreviated New Drug Applications;
Opportunity for a Hearing.'' The request for a hearing will be placed
in the docket and publicly viewable at https://www.regulations.gov or
at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday. The ANDA holder 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:
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 https://www.regulations.gov
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
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:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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
[[Page 64937]]
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
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:
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.
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-2024-N-3271 for ``Flamingo Pharmaceuticals Ltd.; Proposal To
Withdraw Approval of Two 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
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 https://www.regulations.gov.
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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, [email protected].
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 314.98). The holder 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
------------------------------------------------------------------------
Application No. Drug Holder
------------------------------------------------------------------------
ANDA 207309................. Metronidazole Flamingo
tablet, 250 Pharmaceuticals
milligrams (mg) and Ltd., U.S. Agent
500 mg. for Flamingo
Pharmaceuticals
Ltd., 1125 Gaither
Rd., Rockville, MD
20850.
ANDA 207938................. Piroxicam capsule, Do.
10 mg and 20 mg.
------------------------------------------------------------------------
Therefore, under 21 CFR 314.150(b)(1) and Sec. 314.200 (21 CFR
314.200), notice is given to the holder 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 holder has failed to submit reports required
under Sec. 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 holder is hereby provided an opportunity for a
hearing to show why the approval of the ANDAs 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 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
[[Page 64938]]
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 https://www.regulations.gov.
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.
Dated: August 2, 2024.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 2024-17515 Filed 8-7-24; 8:45 am]
BILLING CODE 4164-01-P