[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]


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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.

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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 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
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       Application No.                Drug                 Holder
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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.
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    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