Results
The eRulemaking Program
09/23/2024 | Press release | Distributed by Public on 09/23/2024 07:27
Withdrawal of Approval of Drug Application: Progynon Associates, et al.
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.
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Approval is withdrawn as of September 23, 2024.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 § 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. |
FDA finds that the holders of the NDAs listed in table 1 have repeatedly failed to submit reports required by § 314.81. In addition, under § 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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