[Federal Register Volume 89, Number 54 (Tuesday, March 19, 2024)]
[Notices]
[Page 19597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1181]


Air Products and Chemicals, 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) 205864 and the 
new animal drug application (NADA) 141-395 for the designated medical 
gas Helium, USP held by Air Products and Chemicals, Inc., 1940 Air 
Products Blvd., Allentown, PA 18106-5500 (Air Products). Air Products 
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withdrawn.

DATES: Approval is withdrawn as of April 18, 2024.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, [email protected]; or Scott Fontana (HFV-180), 
Center for Veterinary Medicine, Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-0656, 
[email protected].

SUPPLEMENTARY INFORMATION: Air Products has informed FDA that it is no 
longer marketing the designated medical gas Helium, USP and has 
requested that FDA withdraw approval of NDA 205864 and NADA 141-395 
under the processes in Sec.  314.150(copyright) (21 CFR 314.150(c)) and 
Sec.  514.115(d) (21 CFR 514.115(d)). Air Products 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 205864 and NADA 141-395, and all 
amendments and supplements thereto, are hereby withdrawn as of April 
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 Air Products pursuant to these applications that is in 
inventory on April 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: March 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05742 Filed 3-18-24; 8:45 am]
BILLING CODE 4164-01-P