[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Page 77515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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DATES: Approval is withdrawn as of September 23, 2024.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, [email protected].

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]
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