FDA Assigns NDA 214937 for Helium Inhalation Product by Westair Gases

The U.S. Food and Drug Administration (FDA) has recorded a new drug application (NDA) numbered 214937 for a helium inhalation product. The product is marketed under the brand name HELIUM, USP and is classified as a prescription gas for inhalation. The sponsor of the application is Westair Gases & Equipment Inc. The submission is an original (ORIG) filing, with submission number 1 and a status listed as AP. The submission status date is June 27, 2020, and the FDA issued a correspondence letter on July 20, 2020 (see FDA letter: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214937Orig1s000MGltr.pdf). No reference drug or reference standard is indicated for this product, and the active ingredient is listed simply as HELIUM with no strength specified. The dosage form is GAS and the route of administration is INHALATION.