Notice2024-24106
Linde, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP
Primary source
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Published
October 18, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) 205851 and the new animal drug application (NADA) 141-389 for the designated medical gas Helium, USP held by Linde, Inc., 175 East Park Dr., Tonawanda, NY 14150-7844. Linde, Inc. notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
Full Text
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<title>Federal Register, Volume 89 Issue 202 (Friday, October 18, 2024)</title>
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[Federal Register Volume 89, Number 202 (Friday, October 18, 2024)]
[Notices]
[Pages 83883-83884]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-24106]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4560]
Linde, Inc.; Withdrawal of Approval of a New Drug Application and
New Animal Drug Application for Helium, USP
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 the new drug application (NDA) 205851 and the
new animal drug application (NADA) 141-389 for the designated medical
gas Helium, USP held by Linde, Inc., 175 East Park Dr., Tonawanda, NY
14150-7844. Linde, Inc. notified the Agency in writing that the drug
product was no longer marketed and requested that the approval of the
application be withdrawn.
DATES: Approval is withdrawn as of November 18, 2024.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#793210141b1c0b150057351c110b1f1c151d391f1d185711110a571e160f"><span class="__cf_email__" data-cfemail="eda684808f889f8194c3a188859f8b888189ad8b898cc385859ec38a829b">[email protected]</span></a>; or Scott Fontana (HFV-180),
Center for Veterinary Medicine, Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0656,
<a href="/cdn-cgi/l/email-protection#f7a494988383d9b1989983969996b7919396d99f9f84d9909881"><span class="__cf_email__" data-cfemail="2271414d56560c644d4c56434c43624446430c4a4a510c454d54">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: On March 12, 2024, Linde, Inc. informed FDA
that it is no longer marketing the designated medical gas Helium, USP
and requested that FDA withdraw approval of NDA 205851 and NADA 141-389
under the processes in Sec. 314.150(c) (21 CFR 314.150(c)) and Sec.
514.115(d) (21 CFR 514.115(d)). Linde, Inc. has also, by its request,
waived its opportunity for a hearing. Withdrawal of approval of an
application or abbreviated application under Sec. 314.150(c) or an
NADA or abbreviated new animal drug application under Sec. 514.115(d)
is without prejudice to refiling.
Therefore, approval of NDA 205851 and NADA 141-389, and all
amendments and supplements thereto,
[[Page 83884]]
are hereby withdrawn as of November 18, 2024. Introduction or delivery
for introduction into interstate commerce of Helium, USP, without an
approved new drug application or an approved new animal drug
application violates sections 505(a), 512(a), 301(a), and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a), 360b(a)(1),
331(a), and 331(d)). Any Helium, USP manufactured by Linde, Inc.
pursuant to these applications that is in inventory on November 18,
2024 may continue to be dispensed until the inventories have been
depleted or the drug product has reached its expiration date or
otherwise become violative, whichever occurs first.
Dated: October 9, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24106 Filed 10-17-24; 8:45 am]
BILLING CODE 4164-01-P
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