Document ID: FDA-2021-N-1194-0001
Agency: fda
Document Type: Notice
Title: Fresenius Kabi Deutschland GmbH; Withdrawal of Approval of New Drug Application of Hydroxyethyl Starch
Posted Date: 2021-12-09T05:00Z

[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Page 70141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26648]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1194]

Fresenius Kabi Deutschland GmbH; Withdrawal of Approval of New 
Drug Application of Hydroxyethyl Starch

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 a new drug application (NDA) BN 070012/0022 for 
VOLUVEN (6 Percent Hydroxyethyl Starch 130/0.4 in 0.9 Percent Sodium 
Chloride Injection), held by Fresenius Kabi Deutschland GmbH. Fresenius 
Kabi Deutschland GmbH requested in writing that the Agency's approval 
of the application be withdrawn because the drug is no longer being 
marketed and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of January 10, 2022.

FOR FURTHER INFORMATION CONTACT: Myrna Hanna, 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: Fresenius Kabi Deutschland GmbH, Bad 
Homburg, Germany (Authorized U.S. Agent: Fresenius Kabi USA, LLC, Three 
Corporate Dr., Lake Zurich, IL 60047), has requested that FDA withdraw 
approval of NDA BN 070012 sequence 0022, pursuant to Sec.  314.150(c) 
(21 CFR 314.150(c)), because the drug is no longer being marketed. By 
its request, Fresenius Kabi Deutschland GmbH, 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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            Application No.                      Proprietary name
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NDA BN 070012/0022.....................  VOLUVEN (6% Hydroxyethyl Starch
                                          130/0.4 in 0.9% Sodium
                                          Chloride Injection)
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    Therefore, approval of the application listed in the table, and all 
amendments and supplements thereto, is hereby withdrawn as of January 
10, 2022. Introduction or delivery for introduction into interstate 
commerce for products without a new drug application violates section 
301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331(a) and (d)). The drug product that is listed in the table above 
that is in inventory on January 10, 2022 may continue to be dispensed 
until the inventory has been depleted or the drug product has reached 
its expiration date or otherwise becomes violative, whichever occurs 
first.

    Dated: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26648 Filed 12-8-21; 8:45 am]
BILLING CODE 4164-01-P