Skip to Content


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

Document Details

Information about this document as published in the Federal Register.

Enhanced Content

Relevant information about this document from provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Food and Drug Administration, HHS.




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in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Effective September 5, 2017.

Start Further Info


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.

End Further Info End Preamble Start Supplemental 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 § 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.

NDA/ANDAProprietary name
BN 090024Dextran 70, 6% Dextran 70 in 0.9% NaCl Injection.
BN 160767Dextran 40, 10% Dextran 40 in 0.9% NaCl Injection and 10% Dextran 40 in 5% Dextrose.
BN 890104Pentaspan® (10% Pentastarch in 0.9% NaCl Injection in EXCEL Containers).
BA 740283Hespan® (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Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn, effective September 5, 2017.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.

Start Signature

Dated: July 31, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

End Signature End Supplemental Information

[FR Doc. 2017-16377 Filed 8-2-17; 8:45 am]