Notice2022-15629
Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.; Withdrawal of Approval of Three New Drug Applications
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 140 (Friday, July 22, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 140 (Friday, July 22, 2022)]
[Notices]
[Page 43872]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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DATES: Approval is withdrawn as of July 22, 2022.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, <a href="/cdn-cgi/l/email-protection#377c5e5a5552455b4e197b525f4551525b5377515356195f5f4419505841"><span class="__cf_email__" data-cfemail="3e7557535c5b4c524710725b564c585b525a7e585a5f1056564d10595148">[email protected]</span></a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 22, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.