Notice2021-26648
Fresenius Kabi Deutschland GmbH; Withdrawal of Approval of New Drug Application of Hydroxyethyl Starch
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Published
December 9, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 Fresenius Kabi Deutschland GmbH requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.
Full Text
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<title>Federal Register, Volume 86 Issue 234 (Thursday, December 9, 2021)</title>
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[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Page 70141]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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of the application be withdrawn because the drug is no longer being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DATES: Approval is withdrawn as of January 10, 2022.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
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