Hospira Inc., et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications, 28016-28017 [2020-10082]
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Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
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Dated: May 7, 2020.
Lowell J. Schiller,
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0910–0230
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For proposed use of an alternative grade of ethanol, firms
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1081]
Hospira Inc., et al.; Withdrawal of
Approval of Seven Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of seven
abbreviated new drug applications
(ANDAs) from multiple applicants. The
BILLING CODE 4164–01–P
PO 00000
For proposed use of an alternative grade of ethanol, firms
are requested to submit to
FDA information on the ethanol concentration and levels
of impurities listed in the USP
monograph and other potentially harmful impurities in the
manufacturing environment.
FDA Guidance on Conduct of Clinical Trials of Medical Products
during COVID–19 Public Health
Emergency.
related-guidance-documents-industryfda-staff-and-other-stakeholders; the
FDA web page ‘‘Search for FDA
Guidance Documents,’’ available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or https://
www.regulations.gov.
[FR Doc. 2020–10146 Filed 5–11–20; 8:45 am]
0910–0139
0910–0230
0910–0291
0910–0340
0910–0645
Another guidance title referenced in
COVID–19 guidance
The final guidance entitled ‘‘GFI
#269—Enforcement Policy Regarding
Federal VCPR Requirements to
Facilitate Veterinary Telemedicine
During the COVID–19 Outbreak’’
contains no collection of information.
Therefore, clearance by OMB under the
PRA is not required.
Persons with access to the internet
may obtain COVID–19-related guidances
at the FDA web page ‘‘COVID–19Related Guidance Documents for
Industry, FDA Staff, and Other
Stakeholders,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19-
New collection covered by PHE
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the following FDA regulations and
guidance have been approved by OMB
as listed in the following table:
This guidance refers to previously
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These collections of information are
subject to review by OMB under the
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OMB Control
No(s).
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Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
applicants notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
Approval is withdrawn as of
June 11, 2020.
DATES:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
Application No.
Drug
Applicant
ANDA 065232 ......................
Ceftriaxone Sodium for Injection, Equivalent to (EQ) 10
grams (g) base/vial.
Amitriptyline Hydrochloride (HCl) Tablets, 10 milligrams
(mg).
Amitriptyline HCl Tablets, 25 mg ....................................
Amitriptyline HCl Tablets, 50 mg ....................................
Amitriptyline HCl Tablets, 75 mg ....................................
Amitriptyline HCl Tablets, 100 mg ..................................
Amitriptyline HCl Tablets, 150 mg ..................................
Hospira Inc., 275 North Field Dr., Building H1, Lake
Forest, IL 60045.
Par Pharmaceutical Inc., One Ram Ridge Rd., Spring
Valley, NY 10977.
Par Pharmaceutical Inc.
Do.
Do.
Do.
Do.
ANDA 088697 ......................
ANDA
ANDA
ANDA
ANDA
ANDA
088698
088699
088700
088701
088702
......................
......................
......................
......................
......................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of June 11, 2020.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms inadvertently missing
from the table. Introduction or delivery
for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
products that are listed in the table that
are in inventory on June 11, 2020, may
continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10082 Filed 5–11–20; 8:45 am]
BILLING CODE 4164–01–P
jbell on DSKJLSW7X2PROD with NOTICES
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.
SUPPLEMENTARY INFORMATION: The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
28017
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Nurse Faculty Loan
Program—Program Specific Data Form
and Annual Performance Report
Financial Data Form OMB No. 0915–
0314–Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
SUMMARY: In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR have been provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than June 11, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
PO 00000
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Public Comments’’ or by using the
search function.
To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Nurse Faculty Loan Program—Program
Specific Data Form and Annual
Performance Report Financial Data
Form OMB No. 0915–0314–Revision.
Abstract: This clearance request is for
approval of both the Nurse Faculty Loan
Program (NFLP) Program Specific Data
Form and the Annual Performance
Report (APR) Financial Data Form. The
APR Financial Data Form is currently
approved under OMB Approval No.
0915–0314 and the Program Specific
Data Form is currently approved under
OMB Approval No. 0915–0378, both
with the expiration date of July 31,
2020. The APR Form was previously
titled as the Nurse Faculty Loan
Program, Annual Operating Report. For
program efficiency, HRSA is combining
these previously separate ICRs under
OMB No. 0915–0314 and will be
discontinuing OMB No. 0915–0378.
A 60-day notice published in the
Federal Register on February 7, 2020,
vol. 85, No. 26; pp. 7315–7316. There
were no public comments.
Need and Proposed Use of the
Information: Section 846A of the Public
Health Service Act provides the
Secretary of HHS with the authority to
enter into an agreement with schools of
nursing for the establishment and
FOR FURTHER INFORMATION CONTACT:
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]]>Agencies
[Federal Register Volume 85, Number 92 (Tuesday, May 12, 2020)]
[Notices]
[Pages 28016-28017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10082]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1081]
Hospira Inc., et al.; Withdrawal of Approval of Seven Abbreviated
New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of seven abbreviated new drug applications (ANDAs)
from multiple applicants. The
[[Page 28017]]
applicants notified the Agency in writing that the drug products were
no longer marketed and requested that the approval of the applications
be withdrawn.
DATES: Approval is withdrawn as of June 11, 2020.
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: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec. 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 065232................. Ceftriaxone Sodium Hospira Inc., 275
for Injection, North Field Dr.,
Equivalent to (EQ) Building H1, Lake
10 grams (g) base/ Forest, IL 60045.
vial.
ANDA 088697................. Amitriptyline Par Pharmaceutical
Hydrochloride (HCl) Inc., One Ram Ridge
Tablets, 10 Rd., Spring Valley,
milligrams (mg). NY 10977.
ANDA 088698................. Amitriptyline HCl Par Pharmaceutical
Tablets, 25 mg. Inc.
ANDA 088699................. Amitriptyline HCl Do.
Tablets, 50 mg.
ANDA 088700................. Amitriptyline HCl Do.
Tablets, 75 mg.
ANDA 088701................. Amitriptyline HCl Do.
Tablets, 100 mg.
ANDA 088702................. Amitriptyline HCl Do.
Tablets, 150 mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of June
11, 2020. Approval of each entire application is withdrawn, including
any strengths and dosage forms inadvertently missing from the table.
Introduction or delivery for introduction into interstate commerce of
products without approved new drug applications violates section 301(a)
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in the table that are in
inventory on June 11, 2020, may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.
Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10082 Filed 5-11-20; 8:45 am]
BILLING CODE 4164-01-P
