B. Braun Medical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Hydroxyethyl Starch
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) BA110013/0032 for 6 Percent Hydroxyethyl Starch 130/0.4 in 0.9 Percent Sodium Chloride Injection in EXCEL[supreg] Plastic Container, held by B. Braun Medical, Inc. B. Braun Medical, Inc., requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.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 181 (Wednesday, September 22, 2021)</title>
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[Federal Register Volume 86, Number 181 (Wednesday, September 22, 2021)]
[Notices]
[Page 52685]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20511]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0921]
B. Braun Medical, Inc.; Withdrawal of Approval of Abbreviated 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 abbreviated new drug application (ANDA)
BA110013/0032 for 6 Percent Hydroxyethyl Starch 130/0.4 in 0.9 Percent
Sodium Chloride Injection in EXCEL[supreg] Plastic Container, held by
B. Braun Medical, Inc. B. Braun Medical, Inc., 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that the Agency's approval of the application be withdrawn because the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DATES: Approval is withdrawn as of October 22, 2021.
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: B. Braun Medical Inc., 901 Marcon Blvd.,
Allentown, PA 18109, has requested that FDA withdraw approval of ANDA
BA110013/0032, pursuant to Sec. 314.150(c) (21 CFR 314.150(c)),
because the drug is no longer being marketed. By its request, B. Braun
Medical Inc. 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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ANDA BA 110013/0032....................... 6% Hydroxyethyl Starch 130/
0.4 in 0.9% Sodium Chloride
Injection in EXCEL[supreg]
Plastic Container.
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Therefore, approval of the application listed in the table, and all
amendments and supplements thereto, is hereby withdrawn as of October
22, 2021. Introduction or delivery for introduction into interstate
commerce for products without an approved new drug application or ANDA
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 October 22, 2021 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: September 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20511 Filed 9-21-21; 8:45 am]
BILLING CODE 4164-01-P
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