Document ID: FDA-2020-N-2029-0238
Agency: fda
Document Type: Notice
Title: Proposal To Withdraw Approval of MAKENA; Hearing; Correction
Posted Date: 2022-09-07T04:00Z

[Federal Register Volume 87, Number 172 (Wednesday, September 7, 2022)]
[Notices]
[Page 54700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19293]

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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.

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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, 
[email protected].

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]
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