Ferring Pharmaceuticals, Inc.; Withdrawal of Approval of Two Abbreviated New Drug Applications, 27784 [2018-12762]
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27784
Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2156]
Ferring Pharmaceuticals, Inc.;
Withdrawal of Approval of Two
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
withdrawing approval of two
abbreviated new drug applications
(ANDAs) from Ferring Pharmaceuticals,
Inc. (Ferring). Ferring 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applications be withdrawn.
DATES: Approval is withdrawn as of July
16, 2018.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
Ferring
has informed FDA that the drug
products listed in the table are no longer
marketed and has requested that FDA
withdraw approval of the applications
under the process described in
§ 314.150(c) (21 CFR 314.150(c)).
Ferring has also, by its request, waived
its opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 073598 .....
Menotropins (follicle-stimulating hormone (FSH)/luteinizing hormone
(LH)) for Injection, 75 international units (IU)/75 IU per vial.
Menotropins (FSH/LH) for Injection, 150 IU/150 IU per vial .................
Ferring Pharmaceuticals, Inc., 100 Interpace Pkwy.,
Parsippany, NJ 07054.
Do.
ANDA 073599 .....
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of July 16, 2018.
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 July 16, 2018
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: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12762 Filed 6–13–18; 8:45 am]
BILLING CODE 4164–01–P
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; Zika Virus Pilot Project, OMB
No. 0906–xxxx—NEW
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
daltland on DSKBBV9HB2PROD with NOTICES
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
SUMMARY:
VerDate Sep<11>2014
16:38 Jun 13, 2018
Jkt 244001
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than July 16, 2018.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: 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: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Zika Virus Pilot Project, OMB No. 0906–
xxxx—NEW
Abstract: HRSA is requesting the
Organ Procurement and Transplantation
Network (OPTN) perform a federally
sponsored data collection as part of a
pilot project to monitor the testing of
deceased potential donors possibly
exposed to the Zika virus (ZIKV). The
Zika Pilot Project will have a 12-month
performance period enabling OPTN to
develop a plan to collect data on ways
for organ procurement organizations
(OPOs) to deploy ZIKV donor screening
tests of blood products. The testing is
available under an investigational new
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
drug application for use on a voluntary
basis in the evaluation of deceased
persons as potential solid organ donors.
OPTN will conduct an analysis of the
data collected under this project to
determine the potential effect of making
available screening tests for ZIKV, when
appropriate, to improve transplant
safety. OPTN will convene a group of
stakeholders to provide guidance and
monitor progress on the ZIKV pilot
project.
Need and Proposed Use of the
Information: ZIKV is prevalent in
several areas of the United States.
Currently, there is not a ZIKV screening
procedure for OPOs to implement
during the organ allocation process.
HRSA requested OPTN to conduct a
pilot project to monitor the testing of
deceased donors potentially exposed to
ZIKV. The goals of the pilot project are
to:
• Collaborate with experts to define
necessary data elements to understand
the impact of ZIKV testing in deceased
organ donors;
• Deploy a data collection tool to a
limited number of OPOs that agree to
participate in the pilot project; and
• Assess the ability of OPTN to
respond to a public health situation by
collecting data from impacted members
of the transplant community to assess
the national experience.
Likely Respondents: Organ
Procurement Organizations.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
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]]>Agencies
[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Page 27784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12762]
[[Page 27784]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2156]
Ferring Pharmaceuticals, Inc.; Withdrawal of Approval of Two
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 two abbreviated new drug applications (ANDAs)
from Ferring Pharmaceuticals, Inc. (Ferring). Ferring 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 July 16, 2018.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
[email protected].
SUPPLEMENTARY INFORMATION: Ferring has informed FDA that the drug
products listed in the table are no longer marketed and has requested
that FDA withdraw approval of the applications under the process
described in Sec. 314.150(c) (21 CFR 314.150(c)). Ferring has also, by
its request, waived its 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 073598................... Menotropins (follicle- Ferring
stimulating hormone Pharmaceuticals
(FSH)/luteinizing , Inc., 100
hormone (LH)) for Interpace
Injection, 75 Pkwy.,
international units Parsippany, NJ
(IU)/75 IU per vial. 07054.
ANDA 073599................... Menotropins (FSH/LH) Do.
for Injection, 150 IU/
150 IU per vial.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of July
16, 2018. 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 July 16, 2018 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: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12762 Filed 6-13-18; 8:45 am]
BILLING CODE 4164-01-P
