Document ID: FDA-2021-N-1252-0002
Agency: fda
Document Type: Notice
Title: Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.; Withdrawal of Approval of Three New Drug Applications
Posted Date: 2022-07-22T04:00Z

[Federal Register Volume 87, Number 140 (Friday, July 22, 2022)]
[Notices]
[Page 43872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15629]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1252]

Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.; 
Withdrawal of Approval of Three New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three 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DATES: Approval is withdrawn as of July 22, 2022.

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 December 27, 2021 (86 FR 73296), FDA 
published a notice offering an opportunity for a hearing (NOOH) on a 
proposal to withdraw approval of three 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 three applications listed in table 1 of this document.

     Table 1--Approved NDAs for Which Required Reports Have Not Been
                                Submitted
------------------------------------------------------------------------
      Application No.                Drug                NDA holder
------------------------------------------------------------------------
NDA 008284................  Cortisone Acetate      Panray Corp. Sub
                             Tablets, 5             Ormont Drug and
                             milligrams (mg) and    Chemical Co., Inc.,
                             25 mg.                 520 South Dean St.,
                                                    Englewood, NJ 07631.
NDA 009659................  Hydrocortisone         Do.
                             Tablets, 10 mg and
                             20 mg.
NDA 019503................  Triamcinolone          Parnell
                             Acetonide              Pharmaceuticals
                             Suspension, 3 mg/      Inc., 111 Francisco
                             milliliters (mL).      Blvd., San Rafael,
                                                    CA 94901.
------------------------------------------------------------------------

    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 is hereby 
withdrawn as of July 22, 2022.

    Dated: July 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15629 Filed 7-21-22; 8:45 am]
BILLING CODE 4164-01-P