[Federal Register Volume 89, Number 103 (Tuesday, May 28, 2024)]
[Notices]
[Pages 46139-46141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

    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

[[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:
     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-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 https://www.regulations.gov 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:
     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 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-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 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: 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, [email protected].

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.
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    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 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: 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