Notice2025-09781
Meda AB and B. Braun Medical, Inc.; Withdrawal of Approval of Two New Drug Applications
Primary source
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Published
May 30, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of two new drug applications (NDAs) from two applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
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<title>Federal Register, Volume 90 Issue 103 (Friday, May 30, 2025)</title>
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[Federal Register Volume 90, Number 103 (Friday, May 30, 2025)]
[Notices]
[Page 23055]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-09781]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1138]
Meda AB and B. Braun Medical, Inc.; Withdrawal of Approval of Two
New Drug Applications
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 two new drug applications (NDAs) from two
applicants. The applicants notified the Agency in writing that the drug
products were no longer marketed and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of June 30, 2025.
FOR FURTHER INFORMATION CONTACT: Jennifer Scharpf, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 240-402-8437.
SUPPLEMENTARY INFORMATION: The applicants listed in table 1 have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have
also, by their requests, waived their opportunity for a hearing.
Withdrawal of approval of an application under Sec. 314.150(c) is
without prejudice to refiling.
Table 1--NDAs for Which Approval Is Withdrawn
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Application No. Drug Applicant
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NDA 830715.................. Promit (dextran1), Meda AB, C/O Mylan
150 mg/mL. Specialty L.P.,
3711 Collins Ferry
Rd., Morgantown, WV
26505.
NDA 890105.................. Hespan (6% B. Braun Medical,
hetastarch in 0.9% Inc., 824 12th
sodium chloride Ave., PA 18018.
injection) in Excel
Plastic Container.
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of June 30,
2025. Approval of each entire application is withdrawn, including any
strengths and dosage forms inadvertently missing from table 1.
Introduction or delivery for introduction into interstate commerce of
products listed in table 1 without an approved new drug application
violates sections 505(a) and 301(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are
listed in table 1 that are in inventory on June 30, 2025 may continue
to be dispensed until the inventories have been depleted or the drug
products have reached their expiration dates or otherwise become
violative, whichever occurs first.
Dated: May 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09781 Filed 5-29-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on May 30, 2025.
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