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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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.
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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.
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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.
|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Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn, effective September 5, 2017.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.
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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