82 FR 36150 - B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 148 (August 3, 2017)

Page Range		36150-36150
FR Document		2017-16377

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Federal Register, Volume 82 Issue 148 (Thursday, August 3, 2017)

[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Page 36150]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16377]


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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.

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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applications be withdrawn.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

36150 Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices

SUMMARY: The Food and Drug resolving patent disputes between a ACTION: Notice.
Administration (FDA) is publishing 351(k) BLA applicant and the holder of
notice that an applicant for a proposed the BLA reference product. If a 351(k) SUMMARY: The Food and Drug
biosimilar product notified FDA that a applicant is served with a complaint for Administration (FDA or Agency) is
patent infringement action was filed in a patent infringement described in withdrawing approval of three new drug
connection with the applicant’s section 351(l)(6) of the PHS Act, the applications (NDAs) and one
biologics license application (BLA). applicant is required to provide FDA abbreviated new drug application
Under the Public Health Service Act with notice and a copy of the complaint (ANDA) held by B. Braun Medical, Inc.
(PHS Act), an applicant for a proposed within 30 days of service. FDA is B. Braun Medical, Inc., notified the
biosimilar product or interchangeable required to publish notice of a
Agency in writing that the drug
product must notify FDA within 30 days complaint received under section
351(l)(6)(C) of the PHS Act in the products were no longer marketed and
after the applicant was served with a
Federal Register. requested that the approval of the
complaint in a patent infringement
FDA received notice of the following applications be withdrawn.
action described under the PHS Act.
FDA is required to publish notice of the complaint under section 351(l)(6)(C) of DATES: Effective September 5, 2017.
complaint in the Federal Register. the PHS Act: Amgen, Inc., et al. v.
Coherus Biosciences, Inc., 17–cv–00546 FOR FURTHER INFORMATION CONTACT:
FOR FURTHER INFORMATION CONTACT:
(D. Del., filed May 10, 2017). Valerie A. Butler, Center for Biologics
Daniel Orr, Center for Drug Evaluation FDA has only a ministerial role in Evaluation and Research, Food and
and Research, Food and Drug publishing notice of a complaint Drug Administration, 10903 New
Administration, 10903 New Hampshire received under section 351(l)(6)(C) of Hampshire Ave., Bldg. 71, Rm. 7301,
Ave., Bldg. 51, Rm. 6246, Silver Spring, the PHS Act and does not perform a Silver Spring, MD 20993–0002, 240–
MD 20993–0002, 240–402–0979, substantive review of the complaint.
daniel.orr@fda.hhs.gov. 402–7911.
Dated: July 31, 2017.
SUPPLEMENTARY INFORMATION: The SUPPLEMENTARY INFORMATION: B. Braun
Anna K. Abram, Medical, Inc., 901 Marcon Blvd.,
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was Deputy Commissioner for Policy, Planning, Allentown, PA 18109, has informed
Legislation, and Analysis.
enacted as part of the Patient Protection FDA that the following three NDAs and
[FR Doc. 2017–16380 Filed 8–2–17; 8:45 am]
and Affordable Care Act (Pub. L. 111– one ANDA are no longer marketed and
148) on March 23, 2010. The BPCI Act BILLING CODE 4164–01–P
has requested that FDA withdraw
amended the PHS Act and created an approval of the applications under the
abbreviated licensure pathway for process in § 314.150(c) (21 CFR
DEPARTMENT OF HEALTH AND
biological products shown to be 314.150(c)). By its request, B. Braun
HUMAN SERVICES
biosimilar to, or interchangeable with, Medical, Inc., has also waived its
an FDA-licensed biological reference Food and Drug Administration opportunity for a hearing. Withdrawal
product. Section 351(k) of the PHS Act of approval of an application under
(42 U.S.C. 262(k)), added by the BPCI [Docket No. FDA–2017–N–0002]
§ 314.150(c) is without prejudice to
Act, describes the requirements for a refiling.
B. Braun Medical, Inc.; Withdrawal of
BLA for a proposed biosimilar product
Approval of Three New Drug
or a proposed interchangeable product
Applications and One Abbreviated New
(351(k) BLA). Section 351(l) of the PHS
Drug Application
Act, also added by the BPCI Act,
describes certain procedures for AGENCY: Food and Drug Administration,
exchanging patent information and HHS.

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® (10% Pentastarch in 0.9% NaCl Injection in EXCEL Containers).
BA 740283 ..................................................... Hespan® (6% Hetastarch in 0.9% NaCl in EXCEL Containers).

Therefore, approval of the drug products have reached their DEPARTMENT OF HEALTH AND
applications listed in the table, and all expiration dates or otherwise becomes HUMAN SERVICES
amendments and supplements thereto, violative, whichever occurs first.
is hereby withdrawn, effective Office of the Secretary
Dated: July 31, 2017.
September 5, 2017. Introduction or
Anna K. Abram, Findings of Research Misconduct
delivery for introduction into interstate
commerce for products without an Deputy Commissioner for Policy, Planning,
AGENCY: Office of the Secretary, HHS.
approved NDA or ANDA violates Legislation, and Analysis.
[FR Doc. 2017–16377 Filed 8–2–17; 8:45 am]
ACTION: Notice.
section 301(a) and (d) of the Federal
mstockstill on DSK30JT082PROD with NOTICES

Food, Drug, and Cosmetic Act (21 U.S.C. BILLING CODE 4164–01–P Notice is hereby given that the Office
331(a) and (d)). Drug products that are of Research Integrity (ORI) has taken
listed in the table that are in inventory final action in the following case:
on the date that this notice becomes Nasser Chegini, Ph.D., University of
effective (see the DATES section) may Florida: Based on the report of an
continue to be dispensed until the investigation conducted by the
inventories have been depleted or the University of Florida (UF), the prior

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Document Created: 2017-08-03 07:24:45
Document Modified: 2017-08-03 07:24:45

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Effective September 5, 2017.
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.
FR Citation		82 FR 36150

82 FR 36150 - B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 148 (August 3, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration