Notice2024-05742
Air Products and Chemicals, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP
Primary source
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Published
March 19, 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) 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Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
Full Text
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<title>Federal Register, Volume 89 Issue 54 (Tuesday, March 19, 2024)</title>
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[Federal Register Volume 89, Number 54 (Tuesday, March 19, 2024)]
[Notices]
[Page 19597]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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withdrawn.
DATES: Approval is withdrawn as of April 18, 2024.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, <a href="/cdn-cgi/l/email-protection#753e1c18171007190c5b39101d0713101911351311145b1d1d065b121a03"><span class="__cf_email__" data-cfemail="c78caeaaa5a2b5abbee98ba2afb5a1a2aba387a1a3a6e9afafb4e9a0a8b1">[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#2477474b50500a624b4a50454a45644240450a4c4c570a434b52"><span class="__cf_email__" data-cfemail="cc9fafa3b8b8e28aa3a2b8ada2ad8caaa8ade2a4a4bfe2aba3ba">[email protected]</span></a>.
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
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