Proposal To Withdraw Approval of MAKENA; Hearing; Correction
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.
Issuing agencies
Abstract
The Food and Drug Administration (FDA) is correcting a notice entitled "Proposal To Withdraw Approval of MAKENA; Hearing" that appeared in the Federal Register of August 17, 2022. The document announced the hearing on the Center for Drug Evaluation and Research's proposal to withdraw approval of MAKENA (hydroxyprogesterone caproate injection, 250 milligrams per milliliter, once weekly), new drug application 021945, held by Covis Pharma Group/Covis Pharma GmbH. The document was published with an incorrect deadline. This document corrects that error.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 172 (Wednesday, September 7, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 172 (Wednesday, September 7, 2022)]
[Notices]
[Page 54700]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19293]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2029]
Proposal To Withdraw Approval of MAKENA; Hearing; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of hearing; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
entitled ``Proposal To Withdraw Approval of MAKENA; Hearing'' that
appeared in the Federal Register of August 17, 2022. The document
announced the hearing on the Center for Drug Evaluation and Research's
proposal to withdraw approval of MAKENA (hydroxyprogesterone caproate
injection, 250 milligrams per milliliter, once weekly), new drug
application 021945, held by Covis Pharma Group/Covis Pharma GmbH. The
document was published with an incorrect deadline. This document
corrects that error.
FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931,
<a href="/cdn-cgi/l/email-protection#c2b0a3a1aaa3a7aeecaeabacadb5a7b182a4a6a3ecaaaab1eca5adb4"><span class="__cf_email__" data-cfemail="9ceefdfff4fdf9f0b2f0f5f2f3ebf9efdcfaf8fdb2f4f4efb2fbf3ea">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 17, 2022
(87 FR 50626), in FR Doc. 2022-17715, on page 50628, the following
correction is made:
1. On page 50628, in the last paragraph of the second column, in
the first sentence, ``September 6, 2022'' is corrected to ``September
14, 2022.''
Dated: September 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19293 Filed 9-6-22; 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>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.