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6/22/2021

Ammonia Inhalant

Products Affected - Description

    • Ammonia inhalation, X-Gen, 0.33 mL ampule, 10 count, NDC 39822-9900-01
    • Ammonia inhalation, X-Gen, 0.33 mL ampule, 12 count, NDC 39822-9900-02

Reason for the Shortage

    • The CARES Act signed into law on 3/27/2020 included reforms to the regulation of OTC products. As part of the this law, suppliers are required to review the regulatory history of the active ingredients for any of marketed drug products that were not approved under a new (or abbreviated) drug application or followed an OTC monograph. Ammonia Inhalants falls under the "Category II" active ingredients category and the CARES Act stipulated that Category II drugs are now deemed to be "new drugs" and required a new drug application, within 180 days from the enactment of the law, in order to continue to be marketed, unless FDA determined it was in the interest of the public health to extend the period during which a specific drug may be marketed without an approval. X-Gen has reached out to FDA for guidance to see if this product may qualify for a public health need.

Available Products

    • There are no presentations available

Estimated Resupply Dates

    • X-Gen has ammonia inhalants temporarily unavailable and the company cannot estimate a release date.

Updated

Created June 22, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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