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)

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in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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applications be withdrawn.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

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               NDA/ANDA                         Proprietary name
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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).
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    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