Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications; Correction, 2616 [2022-00831]
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Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Notices
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Dated: January 11, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
holder informed FDA that it submitted
annual reports for ANDA 075941.
Therefore, FDA rescinds its withdrawal
of approval of ANDA 075941. The
approval of ANDA 075941 is still in
effect.
FOR FURTHER INFORMATION CONTACT:
James Hanratty, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1671,
Silver Spring, MD 20993–0002, 240–
402–4718, James.Hanratty@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Corrections
In the Federal Register of Friday,
October 22, 2021 (86 FR 58675), in FR
Doc. 2021–23075, the following
corrections are made:
1. On page 58675, in the second
column, correct the DATES section to
read: DATES: Approval is withdrawn as
of October 22, 2021.’’
2. On page 58679, in the table, remove
the entry for ANDA 075941.
Dated: January 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–00831 Filed 1–14–22; 8:45 am]
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[FR Doc. 2022–00745 Filed 1–14–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1037]
Fresenius USA, Inc., et al.; Withdrawal
of Approval of 216 Abbreviated New
Drug Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of October 22, 2021. The
document announced the withdrawal of
approval of 216 abbreviated new drug
applications (ANDAs) from multiple
applicants, as of November 22, 2021.
The document was published with an
incorrect date. In addition, the
document indicated that FDA was
withdrawing approval of ANDA 075941,
Strontium Chloride SR–89 Injection, 1
millicurie/milliliter, held by BioNucleonics, Inc., 1600 Market St., Suite
13200, Philadelphia, PA 19103, for
repeated failure to submit annual
reports. Before FDA withdrew the
approval of this ANDA, the application
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
[Docket No. FDA–2021–P–0885]
Determination That PEPCID
(Famotidine) Tablet, 20 Milligrams and
40 Milligrams, Was Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
SUMMARY:
Food and Drug Administration
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that PEPCID (famotidine)
tablet, 20 milligrams (mg) and 40 mg,
was not withdrawn from sale for reasons
of safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
SUMMARY:
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]]>Agencies
[Federal Register Volume 87, Number 11 (Tuesday, January 18, 2022)]
[Notices]
[Page 2616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00831]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1037]
Fresenius USA, Inc., et al.; Withdrawal of Approval of 216
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 October 22, 2021. The document
announced the withdrawal of approval of 216 abbreviated new drug
applications (ANDAs) from multiple applicants, as of November 22, 2021.
The document was published with an incorrect date. In addition, the
document indicated that FDA was withdrawing approval of ANDA 075941,
Strontium Chloride SR-89 Injection, 1 millicurie/milliliter, held by
Bio-Nucleonics, Inc., 1600 Market St., Suite 13200, Philadelphia, PA
19103, for repeated failure to submit annual reports. Before FDA
withdrew the approval of this ANDA, the application holder informed FDA
that it submitted annual reports for ANDA 075941. Therefore, FDA
rescinds its withdrawal of approval of ANDA 075941. The approval of
ANDA 075941 is still in effect.
FOR FURTHER INFORMATION CONTACT: James Hanratty, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-
402-4718, [email protected].
SUPPLEMENTARY INFORMATION:
Corrections
In the Federal Register of Friday, October 22, 2021 (86 FR 58675),
in FR Doc. 2021-23075, the following corrections are made:
1. On page 58675, in the second column, correct the DATES section
to read: DATES: Approval is withdrawn as of October 22, 2021.''
2. On page 58679, in the table, remove the entry for ANDA 075941.
Dated: January 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00831 Filed 1-14-22; 8:45 am]
BILLING CODE 4164-01-P
