Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications; Correction, 8485 [2018-03925]
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Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices
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abbreviated new drug applications from
multiple applicants, withdrawn as of
July 21, 2017. The document indicated
that FDA was withdrawing approval of
NDA 204508, Clinolipid 20% (olive oil
and soybean oil) USP, 16%/4%, after
receiving a request from the NDA
holder, Baxter Healthcare Corp. (Baxter),
32650 N Wilson Rd., Round Lake, IL
60073. Before the approval of NDA
204508 was withdrawn, Baxter
informed FDA that it did not want the
approval of this NDA withdrawn.
Because Baxter timely requested that
approval of this NDA not be withdrawn,
the approval of NDA 204508 is still in
effect.
FOR FURTHER INFORMATION CONTACT:
Florine Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Wednesday, June 21,
2017, appearing on page 28322 in FR
Doc. 2017–12908, the following
correction is made:
On page 28329, in table 1, the entry
for NDA 204508 is removed.
Dated: February 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–03976 Filed 2–26–18; 8:45 am]
[FR Doc. 2018–03925 Filed 2–26–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2017–N–3203]
[Docket No. FDA–2018–N–0663]
Wyeth Pharmaceuticals Inc. et al.;
Withdrawal of Approval of 121 New
Drug Applications and 161 Abbreviated
New Drug Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
daltland on DSKBBV9HB2PROD with NOTICES
ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of June 21, 2017 (82 FR 28322).
The document announced the
withdrawal of approval of 121 new drug
applications (NDAs) and 161
SUMMARY:
19:49 Feb 26, 2018
AGENCY:
Food and Drug Administration,
HHS.
Notice; correction.
VerDate Sep<11>2014
Tissue Agnostic Therapies in
Oncology: Regulatory Considerations
for Orphan Drug Designation; Public
Workshop; Request for Comments
Jkt 244001
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the following public
workshop entitled ‘‘Tissue Agnostic
Therapies in Oncology: Regulatory
SUMMARY:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
Considerations for Orphan Drug
Designation.’’ The purpose of the public
workshop is to discuss factors FDA
should consider when evaluating drugs
for orphan designation that treat a tissue
agnostic disease or condition in
oncology, and additional factors related
to orphan exclusivity FDA should
consider when approving a product
with a tissue agnostic indication.
DATES: The public workshop will be
held on May 9, 2018, from 9 a.m. to 5
p.m. The public workshop may be
extended or may end early depending
on the level of public participation.
Submit either electronic or written
comments on this public workshop by
June 8, 2018. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503, Section A), Silver Spring,
MD 20993–0002. Entrance for the public
workshop participants (non-FDA
employees) is through Building 1, where
routine security check procedures will
be performed. For parking and security
information, please refer to https://www.
fda.gov/AboutFDA/WorkingatFDA/
BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
You may submit comments as
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filed comments will not be considered.
Electronic comments must be submitted
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the docket unchanged. Because your
comment will be made public, you are
E:\FR\FM\27FEN1.SGM
27FEN1
]]>Agencies
[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Notices]
[Page 8485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03925]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-3203]
Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121
New Drug Applications and 161 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 June 21, 2017 (82 FR 28322).
The document announced the withdrawal of approval of 121 new drug
applications (NDAs) and 161 abbreviated new drug applications from
multiple applicants, withdrawn as of July 21, 2017. The document
indicated that FDA was withdrawing approval of NDA 204508, Clinolipid
20% (olive oil and soybean oil) USP, 16%/4%, after receiving a request
from the NDA holder, Baxter Healthcare Corp. (Baxter), 32650 N Wilson
Rd., Round Lake, IL 60073. Before the approval of NDA 204508 was
withdrawn, Baxter informed FDA that it did not want the approval of
this NDA withdrawn. Because Baxter timely requested that approval of
this NDA not be withdrawn, the approval of NDA 204508 is still in
effect.
FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In the Federal Register of Wednesday, June
21, 2017, appearing on page 28322 in FR Doc. 2017-12908, the following
correction is made:
On page 28329, in table 1, the entry for NDA 204508 is removed.
Dated: February 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03925 Filed 2-26-18; 8:45 am]
BILLING CODE 4164-01-P
