Mikart, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications; Correction, 56074 [2022-19715]
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56074
Federal Register / Vol. 87, No. 176 / Tuesday, September 13, 2022 / Notices
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On page 41322, in the table, the
entries for ANDAs 204180 and 205790
are removed.
Dated: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19715 Filed 9–12–22; 8:45 am]
BILLING CODE 4164–01–P
Dated: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2022–19714 Filed 9–12–22; 8:45 am]
BILLING CODE 4164–01–P
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[Docket No. FDA–2022–N–1349]
Mikart, LLC, et al.; Withdrawal of
Approval of 31 Abbreviated New Drug
Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on July 12, 2022. The
document announced the withdrawal of
approval (as of August 11, 2022) of 31
abbreviated new drug applications
(ANDAs) from multiple applicants. The
document indicated that FDA was
withdrawing approval of the following
ANDAs after receiving withdrawal
requests from USpharma Windlas, LLC,
115 Blue Jay Dr., Suite 101, Liberty, MO
64068: ANDA 204180, Amiloride
Hydrochloride Tablets, 5 milligrams
(mg); and ANDA 205790, Prasugrel
Tablets, Equivalent to (EQ) 5 mg base
and EQ 10 mg base. Before FDA
withdrew the approval of these ANDAs,
USpharma Windlas, LLC, informed FDA
that it did not want the approval of the
ANDAs withdrawn. Because USpharma
Windlas, LLC, timely requested that
approval of ANDAs 204180 and 205790
not be withdrawn, the approvals are still
in effect.
SUMMARY:
jspears on DSK121TN23PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
David C. Horn,
Director, Office of Financial Policy and
Reporting, (202) 260–9658.
[FR Doc. 2022–19780 Filed 9–12–22; 8:45 am]
BILLING CODE 4150–04–P
In the
Federal Register of Tuesday, July 12,
2022 (87 FR 41322), in FR Doc. 2022–
14798, the following correction is made:
SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Declaration That Circumstances Exist
Justifying Authorizations Pursuant to
Section 564 of the Federal Food, Drug,
and Cosmetic Act (Monkeypox)
Department of Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:
The Secretary of Health and
Human Services (HHS) is issuing this
notice pursuant to the Federal Food,
Drug, and Cosmetic (FD&C) Act. On
August 9, 2022, the Secretary
determined pursuant to his authority
under the FD&C Act that there is a
public health emergency, or a
significant potential for a public health
emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
United States citizens living abroad that
involves monkeypox virus.
On the basis of this determination, he
declared on September 7, 2022 that
circumstances exist justifying
authorizations of emergency use of in
vitro diagnostics for detection and/or
diagnosis of infection with the
monkeypox virus, including in vitro
diagnostics that detect and/or diagnose
infection with non-variola
Orthopoxvirus, pursuant to the FD&C
Act.
DATES: The determination was effective
August 9, 2022 and the declaration is
effective September 7, 2022.
FOR FURTHER INFORMATION CONTACT:
Dawn O’Connell, Assistant Secretary for
Preparedness and Response,
Administration for Strategic
Preparedness and Response, Department
of Health and Human Services, 200
Independence Avenue SW, Washington,
DC 20201, Telephone (202) 205–2882
(this is not a toll-free number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Under section 564 of the FD&C Act,
21 U.S.C. 360bbb–3, the Commissioner
of Food and Drugs of the U.S. Food and
Drug Administration (FDA), acting
under delegated authority from the
Secretary of HHS, may issue an
Emergency Use Authorization (EUA)
authorizing: (1) the emergency use of an
unapproved drug, an unapproved or
uncleared device, or an unlicensed
biological product; or (2) an unapproved
use of an approved drug, approved or
cleared device, or licensed biological
product. Before an EUA may be issued,
the Secretary of HHS must declare that
circumstances exist justifying the
authorization based on one of four
E:\FR\FM\13SEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Page 56074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19715]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1349]
Mikart, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New
Drug Applications; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register on July 12, 2022. The document
announced the withdrawal of approval (as of August 11, 2022) of 31
abbreviated new drug applications (ANDAs) from multiple applicants. The
document indicated that FDA was withdrawing approval of the following
ANDAs after receiving withdrawal requests from USpharma Windlas, LLC,
115 Blue Jay Dr., Suite 101, Liberty, MO 64068: ANDA 204180, Amiloride
Hydrochloride Tablets, 5 milligrams (mg); and ANDA 205790, Prasugrel
Tablets, Equivalent to (EQ) 5 mg base and EQ 10 mg base. Before FDA
withdrew the approval of these ANDAs, USpharma Windlas, LLC, informed
FDA that it did not want the approval of the ANDAs withdrawn. Because
USpharma Windlas, LLC, timely requested that approval of ANDAs 204180
and 205790 not be withdrawn, the approvals are still in effect.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, July 12,
2022 (87 FR 41322), in FR Doc. 2022-14798, the following correction is
made:
On page 41322, in the table, the entries for ANDAs 204180 and
205790 are removed.
Dated: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19715 Filed 9-12-22; 8:45 am]
BILLING CODE 4164-01-P
