Notice2024-21680
Progynon Associates, et al.; Withdrawal of Approval of Four New Drug Applications
Primary source
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Published
September 23, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is withdrawing approval of four new drug applications (NDAs) from multiple holders of those NDAs. The basis for the withdrawal is that these NDA holders have repeatedly failed to file required annual reports for the identified NDAs.
Full Text
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<title>Federal Register, Volume 89 Issue 184 (Monday, September 23, 2024)</title>
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[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Page 77515]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21680]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2219]
Progynon Associates, et al.; Withdrawal of Approval of Four New
Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of four new drug applications (NDAs) from multiple holders of those
NDAs. The basis for the withdrawal is that these NDA holders have
repeatedly failed to file required annual reports for the identified
NDAs.
DATES: Approval is withdrawn as of September 23, 2024.
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#d49fbdb9b6b1a6b8adfa98b1bca6b2b1b8b094b2b0b5fabcbca7fab3bba2"><span class="__cf_email__" data-cfemail="f6bd9f9b9493849a8fd8ba939e8490939a92b6909297d89e9e85d8919980">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The holder of an approved application to
market a new drug for human use is required to submit annual reports to
FDA concerning its approved application in accordance with Sec. 314.81
(21 CFR 314.81).
In the Federal Register of May 28, 2024 (89 FR 46139), FDA
published a notice offering an opportunity for a hearing (NOOH) on a
proposal to withdraw approval of four NDAs because the holders of those
NDAs had repeatedly failed to submit the required annual reports for
those NDAs. The holders of those NDAs did not respond to the NOOH.
Failure to file a written notice of participation and request for
hearing as required by Sec. 314.200 (21 CFR 314.200) constitutes an
election by those holders of the NDAs not to make use of the
opportunity for a hearing concerning the proposal to withdraw approval
of their NDAs and a waiver of any contentions concerning the legal
status of the drug products. Therefore, FDA is withdrawing approval of
the four applications listed in table 1 of this document.
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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FDA finds that the holders of the NDAs listed in table 1 have
repeatedly failed to submit reports required by Sec. 314.81. In
addition, under Sec. 314.200, FDA finds that the holders of the NDAs
have waived any contentions concerning the legal status of the drug
products. Therefore, under these findings, approval of the NDAs listed
in table 1 and all amendments and supplements thereto are hereby
withdrawn as of September 23, 2024.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21680 Filed 9-20-24; 8:45 am]
BILLING CODE 4164-01-P
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