Progynon Associates, et al.; Withdrawal of Approval of Four New Drug Applications, 77515 [2024-21680]

Download as PDF Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices CMS has contracted with an outside vendor to assist in the administration of the RDS program; this effort is called the RDS Center. Plan Sponsors will apply on-line for the retiree drug subsidy by logging on to the RDS Secure website. 42 CFR 423.844 describes the requirement for qualified retiree prescription drug plans who want to receive the retiree drug subsidy. Once the Plan Sponsor submits the RDS application via the RDS Secure website (and a valid initial retiree list) CMS, using its contractor, will analyze the application to determine whether the Plan Sponsor qualifies for the RDS. To qualify for the subsidy, the Plan Sponsor must show that its coverage is as generous as, or more generous than, the defined standard coverage under the Medicare Part D prescription drug benefit. The information within the application includes sponsor account registration information, plan information, benefit options under the plan, actuary information and actuarial attestation. The RDS center has various checks within each section of the application. Applications can be denied if issues cannot be resolved. Form Number: CMS–10170 (OMB control number: 0938–0977); Frequency: Yearly; Affected Public: Private Sector; Business or other for-profits, and Not-for Profits; Number of Respondents: 1,245; Number of Responses: 1,245; Total Annual Hours: 79,680. (For questions regarding this collection, contact Ivan Iveljic at 410–786–3312 or Ivan.iveljic@ cms.hhs.gov.) William N. Parham, III, Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2024–21631 Filed 9–20–24; 8:45 am] BILLING CODE 4120–01–P 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. 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 DATES: Approval is withdrawn as of September 23, 2024.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 SUMMARY: 77515 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. 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. SUPPLEMENTARY INFORMATION: TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED Application No. Drug NDA 004652 ..... ORETON (testosterone) Pellets for Subcutaneous Implantations, 75 milligrams (mg). WINSTEROID (stanozolol) Tablets, 2 mg ................................ Copper T Model TCu 200B (copper) Intrauterine Device ........ NDA 013268 ..... NDA 017455 ..... khammond on DSKJM1Z7X2PROD with NOTICES NDA 205003 ..... Holder 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. 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. Progynon Associates, 9300 Wilshire Blvd., Beverly Hills, CA 90212. Sterling Winthrop Inc., 90 Park Ave., New York, NY 10016. Duramed Research, Inc., 425 Privet Rd., Horsham, PA 19044. Adhera Therapeutics, Inc., 224 Holding Ave., Wake Forest, NC 27588. Dated: September 16, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–21680 Filed 9–20–24; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–3112] BILLING CODE 4164–01–P Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public SUMMARY: VerDate Sep<11>2014 16:57 Sep 20, 2024 Jkt 262001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1

Agencies

[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.

-----------------------------------------------------------------------

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
------------------------------------------------------------------------
       Application No.                Drug                 Holder
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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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