TG United, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications; Correction, 17165 [2021-06745]
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Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Notices
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[FR Doc. 2021–06705 Filed 3–31–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2306]
TG United, Inc., et al.; Withdrawal of
Approval of 27 Abbreviated New Drug
Applications; Correction
Food and Drug Administration,
HHS.
The theme for the 2021 FDA Science
Forum, ‘‘Science as the Foundation for
Protecting and Promoting Public
Health’’, will highlight areas of FDA
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countermeasures, infectious disease,
and pathogen-reduction technologies.
19:02 Mar 31, 2021
Dated: March 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
AGENCY:
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Workshop
VerDate Sep<11>2014
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ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of January 15, 2021. The
document announced the withdrawal of
approval of 27 abbreviated new drug
applications (ANDAs) from multiple
applicants as of February 16, 2021. The
document indicated that FDA was
withdrawing approval of the following
three ANDAs after receiving a
withdrawal request from Upsher-Smith
Laboratories, LLC., 6701 Evenstad Dr.,
Maple Grove, MN 55369: ANDA
084041, Chlordiazepoxide
Hydrochloride (HCl) Capsules, 10
milligrams (mg); ANDA 084678,
Chlordiazepoxide HCl Capsules, 5 mg;
and ANDA 084679, Chlordiazepoxide
HCl Capsules, 25 mg. Before FDA
withdrew the approval of these ANDAs,
Upsher-Smith Laboratories, LLC.,
informed FDA that it did not want the
approval of the ANDAs withdrawn.
Because Upsher-Smith Laboratories,
LLC., timely requested that approval of
these ANDAs not be withdrawn, the
approval of ANDAs 084041, 084678,
and 084679 is still in effect. In addition,
the document indicated that FDA was
PO 00000
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Fmt 4703
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withdrawing approval of ANDA 206061,
Pravastatin Sodium Tablets, 20 mg, 40
mg, and 80 mg, after receiving a request
from Hisun Pharmaceutical (Hangzhou)
Co., Ltd. However, the document
published with the incorrect applicant
name for ANDA 206061. This document
corrects that error. All other information
for ANDA 206061 remains the same.
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.
In the
Federal Register of Friday, January 15,
2021 (86 FR 4081), appearing on page
4081 in FR Doc. 2021–00833, the
following corrections are made on page
4082 in the table:
1. The entries for ANDAs 084041,
084678, and 084679 are removed.
2. In the third column, third item
from the bottom, the applicant name
‘‘Hisun Pharmaceuticals USA, Inc.’’ is
corrected to read ‘‘Hisun
Pharmaceuticals USA, Inc., U.S. Agent
for Hisun Pharmaceutical (Hangzhou)
Co., Ltd.’’ for ANDA 206061.
SUPPLEMENTARY INFORMATION:
Dated: March 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06745 Filed 3–31–21; 8:45 am]
Notice; correction.
SUMMARY:
17165
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0270]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Endocrinologic and
Metabolic Drugs Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to FDA on regulatory issues. The
meeting will be open to the public. FDA
is establishing a docket for public
comment on this document.
SUMMARY:
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[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Page 17165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06745]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2306]
TG United, Inc., et al.; Withdrawal of Approval of 27 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 of January 15, 2021. The document
announced the withdrawal of approval of 27 abbreviated new drug
applications (ANDAs) from multiple applicants as of February 16, 2021.
The document indicated that FDA was withdrawing approval of the
following three ANDAs after receiving a withdrawal request from Upsher-
Smith Laboratories, LLC., 6701 Evenstad Dr., Maple Grove, MN 55369:
ANDA 084041, Chlordiazepoxide Hydrochloride (HCl) Capsules, 10
milligrams (mg); ANDA 084678, Chlordiazepoxide HCl Capsules, 5 mg; and
ANDA 084679, Chlordiazepoxide HCl Capsules, 25 mg. Before FDA withdrew
the approval of these ANDAs, Upsher-Smith Laboratories, LLC., informed
FDA that it did not want the approval of the ANDAs withdrawn. Because
Upsher-Smith Laboratories, LLC., timely requested that approval of
these ANDAs not be withdrawn, the approval of ANDAs 084041, 084678, and
084679 is still in effect. In addition, the document indicated that FDA
was withdrawing approval of ANDA 206061, Pravastatin Sodium Tablets, 20
mg, 40 mg, and 80 mg, after receiving a request from Hisun
Pharmaceutical (Hangzhou) Co., Ltd. However, the document published
with the incorrect applicant name for ANDA 206061. This document
corrects that error. All other information for ANDA 206061 remains the
same.
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 Friday, January
15, 2021 (86 FR 4081), appearing on page 4081 in FR Doc. 2021-00833,
the following corrections are made on page 4082 in the table:
1. The entries for ANDAs 084041, 084678, and 084679 are removed.
2. In the third column, third item from the bottom, the applicant
name ``Hisun Pharmaceuticals USA, Inc.'' is corrected to read ``Hisun
Pharmaceuticals USA, Inc., U.S. Agent for Hisun Pharmaceutical
(Hangzhou) Co., Ltd.'' for ANDA 206061.
Dated: March 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06745 Filed 3-31-21; 8:45 am]
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