Progynon Associates, et al.; Proposal to Withdraw Approval of Four New Drug Applications; Opportunity for a Hearing

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Published

May 28, 2024

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 four new drug applications (NDAs) and is announcing an opportunity for the NDA holders to request a hearing on this proposal. The basis for the proposal is that the NDA holders have repeatedly failed to file required annual reports for those NDAs.

Full Text

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<title>Federal Register, Volume 89 Issue 103 (Tuesday, May 28, 2024)</title>
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[Federal Register Volume 89, Number 103 (Tuesday, May 28, 2024)]
[Notices]
[Pages 46139-46141]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11609]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2219]

Progynon Associates, et al.; Proposal to Withdraw Approval of
Four 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 four new drug applications (NDAs) and is announcing an opportunity
for the NDA holders to request a hearing on this proposal. The basis
for the proposal is that the NDA holders have repeatedly failed to file
required annual reports for those NDAs.

DATES: The NDA holders may submit a request for a hearing by June 27,
2024. Submit all data, information, and analyses upon which the request
for a hearing relies July 29, 2024. Submit electronic or written
comments by July 29, 2024.

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

Electronic Submissions

[[Page 46140]]

any attachments to the request for a hearing, will be posted to the
docket unchanged.

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-2024-N-2219 for ``Progynon Associates, et al.; Proposal
To Withdraw Approval of Four 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
NDA 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
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-2024-N-2219 for ``Progynon Associates, et al.; Proposal To Withdraw
Approval of Four 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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/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: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#62290b0f0007100e1b4c2e070a1004070e06220406034c0a0a114c050d14"><span class="__cf_email__" data-cfemail="4a012327282f38263364062f22382c2f262e0a2c2e2b64222239642d253c">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: The holder of an approved NDA to market a
new drug for human use is required to submit annual reports to FDA
concerning its approved NDA under Sec. Sec. 314.81 and 314.98 (21 CFR
314.81 and 21 CFR 314.98). The holders of the approved NDAs 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.

[[Page 46141]]

Table 1--Approved NDAs for Which Required Reports Have Not Been
Submitted
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Application No. Drug Holder
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NDA 004652.................. ORETON Progynon Associates,
(testosterone) 9300 Wilshire
Pellets for Blvd., Beverly
Subcutaneous Hills, CA 90212.
Implantations, 75
milligrams (mg).
NDA 013268.................. WINSTEROID Sterling Winthrop
(stanozolol) Inc., 90 Park Ave.,
Tablets, 2 mg. New York, NY 10016.
NDA 017455.................. Copper T Model TCu Duramed Research,
200B (copper) Inc., 425 Privet
Intrauterine Device. Rd., Horsham, PA
19044.
NDA 205003.................. PRESTALIA Adhera Therapeutics,
(amlodipine Inc., 224 Holding
besylate/ Ave., Wake Forest,
perindopril NC 27588.
arginine) Tablets,
equivalent to (EQ)
2.5 mg base/3.5mg,
EQ 5 mg base/7 mg,
and EQ 10 mg base/
14 mg.
------------------------------------------------------------------------

Therefore, notice is given to the holders of the approved NDAs
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 NDAs and all amendments and supplements thereto on the
grounds that the NDA holders have failed to submit reports required
under Sec. 314.81.
In accordance with section 505 of the FD&C Act and part 314 (21 CFR
part 314), the NDA holders are hereby provided an opportunity for a
hearing to show why the approval of the NDAs 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 NDAs.
An NDA 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 NDA 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 NDA holder not to avail itself of the
opportunity for a hearing concerning CDER's proposal to withdraw
approval of the NDAs and constitutes a waiver of any contentions
concerning the legal status of the drug products. FDA will then
withdraw approval of the NDAs, 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 NDA 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.

Dated: May 17, 2024.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 2024-11609 Filed 5-24-24; 8:45 am]
BILLING CODE 4164-01-P

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