Document ID: FDA-2012-N-0840-0001
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of New Drug Applications: Hospira, Inc.; DEXTRAN 70
Posted Date: 2012-08-20T04:00Z

[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Notices]
[Page 50121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20280]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0840]

Hospira, Inc.; Withdrawal of Approval of a New Drug Application 
for DEXTRAN 70

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new drug application (NDA) for DEXTRAN 70 (6% Dextran 70 and 0.9% 
NaCl or/5% Dextrose 500 mL Glass Bottle) held by Hospira, Inc., 275 
North Field Dr., Lake Forest, IL 60045. Hospira, Inc., has notified the 
Agency in writing that this product is no longer marketed and has 
requested that approval of the application be withdrawn.

DATES: Effective August 20, 2012.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 
301-827-6210.

SUPPLEMENTARY INFORMATION: Hospira, Inc., has requested that FDA 
withdraw approval of NDA 080-819, DEXTRAN 70 (6% Dextran 70 and 0.9% 
NaCl or/5% Dextrose 500 mL Glass Bottle) under the process in Sec.  
314.150(c)(21 CFR 314.150(c)), stating that the product is no longer 
marketed. By its own request, Hospira, Inc., has also waived its 
opportunity for a hearing provided under Sec.  314.150(a).
    Withdrawal of approval of an application under Sec.  314.150(c) is 
without prejudice to refiling.
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority 
delegated to the Director, Center for Biologics Evaluation and 
Research, by the Commissioner of Food and Drugs, approval of NDA 080-
819, DEXTRAN 70 [6% Dextran 70 and 0.9% NaCl or/5% Dextrose 500 mL 
Glass Bottle], and all amendments and supplements thereto, is hereby 
withdrawn, effective August 20, 2012. Distribution of this product in 
interstate commerce without an approved application is illegal and 
subject to regulatory action (see sections 505(a) and 301(d) of the 
FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: August 9, 2012.
Karen Midthun,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 2012-20280 Filed 8-17-12; 8:45 am]
BILLING CODE 4160-01-P