§Why CasetextPricing

Progynon Associates, et al.; Withdrawal of Approval of Four New Drug Applications

89 Fed. Reg. 77515 (Sep. 23, 2024)

Progynon Associates, et al.; Withdrawal of Approval of Four New Drug Applications

Download PDF
Federal RegisterSep 23, 2024
89 Fed. Reg. 77515 (Sep. 23, 2024)
Document Headings

Document headings vary by document type but may contain the following:

  • the agency or agencies that issued and signed a document
  • the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
  • the agency docket number / agency internal file number
  • the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions

    • See the Document Drafting Handbook for more details.

    Department of Health and Human Services Food and Drug Administration
  • [Docket No. FDA-2024-N-2219]

    • AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    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    Approval is withdrawn as of September 23, 2024.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, Kimberly.Lehrfeld@fda.hhs.gov.

    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 § 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 § 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

    Application No. Drug Holder
    NDA 004652 ORETON (testosterone) Pellets for Subcutaneous Implantations, 75 milligrams (mg) Progynon Associates, 9300 Wilshire Blvd., Beverly Hills, CA 90212.
    NDA 013268 WINSTEROID (stanozolol) Tablets, 2 mg Sterling Winthrop Inc., 90 Park Ave., New York, NY 10016.
    NDA 017455 Copper T Model TCu 200B (copper) Intrauterine Device Duramed Research, Inc., 425 Privet Rd., Horsham, PA 19044.
    NDA 205003 PRESTALIA (amlodipine besylate/perindopril arginine) Tablets, equivalent to (EQ) 2.5 mg base/3.5mg, EQ 5 mg base/7 mg, and EQ 10 mg base/14 mg Adhera Therapeutics, Inc., 224 Holding Ave., Wake Forest, NC 27588.