B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application, 36150 [2017-16377]
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36150
Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices
The Food and Drug
Administration (FDA) is publishing
notice that an applicant for a proposed
biosimilar product notified FDA that a
patent infringement action was filed in
connection with the applicant’s
biologics license application (BLA).
Under the Public Health Service Act
(PHS Act), an applicant for a proposed
biosimilar product or interchangeable
product must notify FDA within 30 days
after the applicant was served with a
complaint in a patent infringement
action described under the PHS Act.
FDA is required to publish notice of the
complaint in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6246, Silver Spring,
MD 20993–0002, 240–402–0979,
daniel.orr@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was
enacted as part of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148) on March 23, 2010. The BPCI Act
amended the PHS Act and created an
abbreviated licensure pathway for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product. Section 351(k) of the PHS Act
(42 U.S.C. 262(k)), added by the BPCI
Act, describes the requirements for a
BLA for a proposed biosimilar product
or a proposed interchangeable product
(351(k) BLA). Section 351(l) of the PHS
Act, also added by the BPCI Act,
describes certain procedures for
exchanging patent information and
SUMMARY:
resolving patent disputes between a
351(k) BLA applicant and the holder of
the BLA reference product. If a 351(k)
applicant is served with a complaint for
a patent infringement described in
section 351(l)(6) of the PHS Act, the
applicant is required to provide FDA
with notice and a copy of the complaint
within 30 days of service. FDA is
required to publish notice of a
complaint received under section
351(l)(6)(C) of the PHS Act in the
Federal Register.
FDA received notice of the following
complaint under section 351(l)(6)(C) of
the PHS Act: Amgen, Inc., et al. v.
Coherus Biosciences, Inc., 17–cv–00546
(D. Del., filed May 10, 2017).
FDA has only a ministerial role in
publishing notice of a complaint
received under section 351(l)(6)(C) of
the PHS Act and does not perform a
substantive review of the complaint.
ACTION:
Dated: July 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2017–16380 Filed 8–2–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0002]
B. Braun Medical, Inc.; Withdrawal of
Approval of Three New Drug
Applications and One Abbreviated New
Drug Application
AGENCY:
mstockstill on DSK30JT082PROD with NOTICES
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn, effective
September 5, 2017. Introduction or
delivery for introduction into interstate
commerce for products without an
approved NDA or ANDA 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 the date that this notice becomes
effective (see the DATES section) may
continue to be dispensed until the
inventories have been depleted or the
16:35 Aug 02, 2017
DATES:
Effective September 5, 2017.
FOR FURTHER INFORMATION CONTACT:
Valerie A. Butler, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
B. Braun
Medical, Inc., 901 Marcon Blvd.,
Allentown, PA 18109, has informed
FDA that the following three NDAs and
one ANDA are no longer marketed and
has requested that FDA withdraw
approval of the applications under the
process in § 314.150(c) (21 CFR
314.150(c)). By its request, B. Braun
Medical, Inc., has also waived its
opportunity for a hearing. Withdrawal
of approval of an application under
§ 314.150(c) is without prejudice to
refiling.
Food and Drug Administration,
Proprietary name
....................................................
....................................................
....................................................
.....................................................
VerDate Sep<11>2014
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of three new drug
applications (NDAs) and one
abbreviated new drug application
(ANDA) held by B. Braun Medical, Inc.
B. Braun Medical, Inc., notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
SUMMARY:
HHS.
NDA/ANDA
BN 090024
BN 160767
BN 890104
BA 740283
Notice.
Jkt 241001
Dextran 70, 6% Dextran 70 in 0.9% NaCl Injection.
Dextran 40, 10% Dextran 40 in 0.9% NaCl Injection and 10% Dextran 40 in 5% Dextrose.
Pentaspan® (10% Pentastarch in 0.9% NaCl Injection in EXCEL Containers).
Hespan® (6% Hetastarch in 0.9% NaCl in EXCEL Containers).
drug products have reached their
expiration dates or otherwise becomes
violative, whichever occurs first.
Dated: July 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16377 Filed 8–2–17; 8:45 am]
Frm 00037
Fmt 4703
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Notice is hereby given that the Office
of Research Integrity (ORI) has taken
final action in the following case:
Nasser Chegini, Ph.D., University of
Florida: Based on the report of an
investigation conducted by the
University of Florida (UF), the prior
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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]]>Agencies
[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Page 36150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16377]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0002]
B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug
Applications and One Abbreviated New Drug Application
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) and one
abbreviated new drug application (ANDA) held by B. Braun Medical, Inc.
B. Braun Medical, Inc., notified the Agency in writing that the drug
products were no longer marketed and requested that the approval of the
applications be withdrawn.
DATES: Effective September 5, 2017.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
SUPPLEMENTARY INFORMATION: B. Braun Medical, Inc., 901 Marcon Blvd.,
Allentown, PA 18109, has informed FDA that the following three NDAs and
one ANDA are no longer marketed and has requested that FDA withdraw
approval of the applications under the process in Sec. 314.150(c) (21
CFR 314.150(c)). By its request, B. Braun Medical, Inc., has also
waived its opportunity for a hearing. Withdrawal of approval of an
application under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
NDA/ANDA Proprietary name
------------------------------------------------------------------------
BN 090024............................. Dextran 70, 6% Dextran 70 in
0.9% NaCl Injection.
BN 160767............................. Dextran 40, 10% Dextran 40 in
0.9% NaCl Injection and 10%
Dextran 40 in 5% Dextrose.
BN 890104............................. Pentaspan[supreg] (10%
Pentastarch in 0.9% NaCl
Injection in EXCEL Containers).
BA 740283............................. Hespan[supreg] (6% Hetastarch in
0.9% NaCl in EXCEL Containers).
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn, effective
September 5, 2017. Introduction or delivery for introduction into
interstate commerce for products without an approved NDA or ANDA
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 the date that this notice becomes
effective (see the DATES section) may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise becomes violative, whichever occurs
first.
Dated: July 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16377 Filed 8-2-17; 8:45 am]
BILLING CODE 4164-01-P
