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.

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