Bayer HealthCare Pharmaceuticals, Inc., et al.; Withdrawal of Approval of Three New Drug Applications, 46406 [2024-11721]
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46406
Federal Register / Vol. 89, No. 104 / Wednesday, May 29, 2024 / Notices
FD&C Act). In addition, FDA will not
accept or review any abbreviated new
drug application from Ms. AnzuresCamarena during her period of
debarment, other than in connection
with an audit under section 306 of the
FD&C Act (section 306(c)(1)(B) of the
FD&C Act). Note that, for purposes of
sections 306 and 307 of the FD&C Act,
a ‘‘drug product’’ is defined as a ‘‘drug
subject to regulation under section 505,
512, or 802 of the FD&C Act (21 U.S.C.
355, 360b, or 382) or under section 351
of the Public Health Service Act (42
U.S.C. 262)’’ (section 201(dd) of the
FD&C Act (21 U.S.C. 321(dd))).
Dated: May 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–11727 Filed 5–28–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2377]
Bayer HealthCare Pharmaceuticals,
Inc., et al.; Withdrawal of Approval of
Three New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of three new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
SUMMARY:
Approval is withdrawn as of
June 28, 2024.
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.
DATES:
The
applicants listed in table 1 have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process 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.
SUPPLEMENTARY INFORMATION:
TABLE 1—NDAS FOR WHICH APPROVAL IS WITHDRAWN
Application No.
NDA 019857 ..........
NDA 021158 ..........
NDA 021473 ..........
Drug
Cipro in Dextrose 5% in Plastic Container (ciprofloxacin)
Injectable, 200 milligrams (mg)/100 milliliters (mL) and
400 mg/200 mL.
Factive (gemifloxacin mesylate) Tablet, Equivalent to (EQ)
320 mg base.
Cipro XR (ciprofloxacin hydrochloride) Extended-Release
Tablet, EQ 287.5 mg base.
lotter on DSK11XQN23PROD with NOTICES1
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of June 28, 2024.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms included in the
application but inadvertently missing
from table 1. Introduction or delivery for
introduction into interstate commerce of
products listed in table 1 without an
approved NDA violates sections 505(a)
and 301(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(a) and
331(d)). Drug products that are listed in
table 1 that are in inventory on June 28,
2024 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 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–11721 Filed 5–28–24; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
Applicant
18:42 May 28, 2024
Jkt 262001
Bayer HealthCare Pharmaceuticals, Inc., 100 Bayer Blvd.,
Whippany, NJ 07981.
LG Chem Ltd., C/O Parexel International, 2520 Meridian
Parkway, Suite 200, Durham, NC 27713.
Bayer HealthCare Pharmaceuticals, Inc.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–1829]
Platform Technology Designation
Program; Draft Guidance for Industry;
Availability; Agency Information
Collection Activities; Proposed
Collection; Comment Request
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a draft
guidance for industry entitled ‘‘Platform
Technology Designation Program for
Drug Development.’’ The purpose of this
draft guidance is to provide details
about the implementation of the
Platform Technology Designation
Program established by the PREVENT
Pandemics Act. This draft guidance
outlines eligibility factors for receiving
a platform technology designation,
potential benefits of receiving a
designation, how to leverage data from
designated platform technologies, how
SUMMARY:
PO 00000
Frm 00049
Fmt 4703
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to discuss the planned designation
request as part of a milestone meeting,
the recommended content of a
designation request submission, and the
review timelines for a designation
request. This draft guidance, when
finalized, will represent the current
thinking of FDA.
DATES: Submit either electronic or
written comments on the draft guidance
by July 29, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
Submit electronic or written comments
on the proposed collection of
information in the draft guidance by
July 29, 2024.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
E:\FR\FM\29MYN1.SGM
29MYN1
]]>Agencies
[Federal Register Volume 89, Number 104 (Wednesday, May 29, 2024)]
[Notices]
[Page 46406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11721]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2377]
Bayer HealthCare Pharmaceuticals, Inc., et al.; Withdrawal of
Approval of Three New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of three new drug applications (NDAs) from
multiple applicants. The 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 28, 2024.
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: The applicants listed in table 1 have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process 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.
Table 1--NDAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 019857............... Cipro in Dextrose 5% Bayer HealthCare
in Plastic Container Pharmaceuticals,
(ciprofloxacin) Inc., 100 Bayer
Injectable, 200 Blvd., Whippany, NJ
milligrams (mg)/100 07981.
milliliters (mL) and
400 mg/200 mL.
NDA 021158............... Factive (gemifloxacin LG Chem Ltd., C/O
mesylate) Tablet, Parexel
Equivalent to (EQ) International, 2520
320 mg base. Meridian Parkway,
Suite 200, Durham,
NC 27713.
NDA 021473............... Cipro XR Bayer HealthCare
(ciprofloxacin Pharmaceuticals,
hydrochloride) Inc.
Extended-Release
Tablet, EQ 287.5 mg
base.
------------------------------------------------------------------------
Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of June 28,
2024. Approval of each entire application is withdrawn, including any
strengths and dosage forms included in the application but
inadvertently missing from table 1. Introduction or delivery for
introduction into interstate commerce of products listed in table 1
without an approved NDA violates sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).
Drug products that are listed in table 1 that are in inventory on June
28, 2024 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 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11721 Filed 5-28-24; 8:45 am]
BILLING CODE 4164-01-P
