[Federal Register Volume 89, Number 202 (Friday, October 18, 2024)]
[Notices]
[Pages 83883-83884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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application be withdrawn.

DATES: Approval is withdrawn as of November 18, 2024.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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