Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 New Drug Applications; Correction, 73483 [2020-25413]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices
proposed generic and follow-on
versions of SPIRIVA HANDIHALER or
any other Boehringer Ingelheim oral
inhalation product containing the active
ingredient tiotropium bromide under
section 505(j) and (b)(2), respectively, of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j) and (b)(2)) (Docket
No. FDA–2012–P–1072). FDA is
reviewing the issues raised in the
petition and will consider any
comments on the draft guidance entitled
‘‘Draft Guidance for Tiotropium
Bromide’’ before responding to
Boehringer’s citizen petition.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the information and data to
demonstrate BE to support ANDAs for
tiotropium bromide inhalation spray. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
Esomeprazole Strontium DelayedRelease Capsules, Equivalent to (EQ) 20
milligrams (mg) base and EQ 40 mg
base, after receiving a withdrawal
request from R2 Pharma, LLC, 11550
North Meridian St., Suite 290, Carmel,
IN 46032–5505 (R2 Pharma). Because of
clerical errors in the Agency’s
processing of communications regarding
this application, FDA has determined
that NDA 202342 remains approved.
Accordingly, FDA’s approval of NDA
202342 remains in effect. There are no
changes with respect to the other 18
NDA withdrawals announced in the
January 8, 2020 Federal Register notice.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Correction
SUPPLEMENTARY INFORMATION:
In the Federal Register of Wednesday,
January 8, 2020 (85 FR 915), appearing
on page 916 in FR Doc. 2020–00075, the
following correction is made:
On page 916, in the table, the entry for
NDA 202342 is removed.
Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25413 Filed 11–17–20; 8:45 am]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
khammond on DSKJM1Z7X2PROD with NOTICES
VerDate Sep<11>2014
17:59 Nov 17, 2020
Jkt 253001
Registration of Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act and
Associated Fees
OMB Control Number 0910–0776—
Revision
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
A. Registration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration of
Human Drug Compounding
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act and Associated Fees
AGENCY:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on January 8, 2020. The
document announced the withdrawal of
approval of 19 new drug applications
(NDAs) from multiple applicants,
withdrawn as of February 7, 2020. The
document indicated that FDA was
withdrawing approval of NDA 202342,
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
This information collection helps to
support implementation of section 503B
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) and the Drug Quality
and Security Act (DQSA).
BILLING CODE 4164–01–P
Food and Drug Administration
Pharmacia and Upjohn Co., et al.;
Withdrawal of Approval of 19 New
Drug Applications; Correction
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2013–N–1429]
[Docket No. FDA–2019–N–5843]
Submit written comments
(including recommendations) on the
collection of information by December
18, 2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0776. Also include
the FDA docket number found in
brackets in the heading of this
document.
DATES:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10 a.m.–12 p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
[FR Doc. 2020–25412 Filed 11–17–20; 8:45 am]
BILLING CODE 4164–01–P
73483
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Under section 503B of the FD&C Act
(21 U.S.C. 353b), added by DQSA, a
facility that compounds drugs may elect
to register with FDA as an outsourcing
facility. Drug products compounded in
a registered outsourcing facility can
qualify for exemptions from the FDAapproval requirements in section 505 of
the FD&C Act (21 U.S.C. 355), the
requirement to label products with
adequate directions for use under
section 502(f)(1) of the FD&C Act (21
U.S.C. 352(f)(1)), and the requirements
for drug supply chain security in section
582 of the FD&C Act (21 U.S.C. 360eee–
1) if the requirements in section 503B of
the FD&C Act have been met.
After the initial registration, under
section 503B(b) of the FD&C Act, a
facility that elects to register with FDA
as an outsourcing facility must also do
so annually between October 1 and
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Notices]
[Page 73483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25413]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5843]
Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19
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 January 8, 2020. The document
announced the withdrawal of approval of 19 new drug applications (NDAs)
from multiple applicants, withdrawn as of February 7, 2020. The
document indicated that FDA was withdrawing approval of NDA 202342,
Esomeprazole Strontium Delayed-Release Capsules, Equivalent to (EQ) 20
milligrams (mg) base and EQ 40 mg base, after receiving a withdrawal
request from R2 Pharma, LLC, 11550 North Meridian St., Suite 290,
Carmel, IN 46032-5505 (R2 Pharma). Because of clerical errors in the
Agency's processing of communications regarding this application, FDA
has determined that NDA 202342 remains approved. Accordingly, FDA's
approval of NDA 202342 remains in effect. There are no changes with
respect to the other 18 NDA withdrawals announced in the January 8,
2020 Federal Register notice.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of Wednesday, January 8, 2020 (85 FR 915),
appearing on page 916 in FR Doc. 2020-00075, the following correction
is made:
On page 916, in the table, the entry for NDA 202342 is removed.
Dated: November 12, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25413 Filed 11-17-20; 8:45 am]
BILLING CODE 4164-01-P
