Air (air)

Where it stands

The records show Air (air), a gas, as approved in the US. The FDA approval is dated 2026-07-19 under NDA221805, and the sponsor is Noble Gas Solutions Inc. The status is recorded as Approved, and the source is marked official.

The records do not give a therapeutic area or an indication. The product's labeled uses, strength, route of administration and presentation are therefore not available here, and this analysis does not infer them.

The records also show an earlier FDA approval of a product with the same name, Air (air), dated 2026-02-02. That approval is under a different application, NDA221287, held by General Air Service & Supply Company. The two approvals are separate applications from separate sponsors. Noble Gas Solutions' approval is not a change to the earlier one.

Regulatory pathway and designations

Both milestones are recorded as FDA approvals under New Drug Applications (NDAs). An NDA approval means the FDA has concluded that the application meets the statutory standards for the product's labeled use, including manufacturing quality. The records give no review details such as review division, review type or approval letter content.

No designations are recorded. The records show no orphan, fast track, breakthrough or priority review status. No PDUFA date is listed, which is consistent with a product already approved. The CHMP opinion date is blank, and no EU or EMA procedure appears in the records. The product is US-only as far as the data show.

Each sponsor holds its own NDA, so each is responsible for its own labeling, manufacturing compliance and post-approval obligations. The records do not say whether the 2026-07-19 application relied on published literature, on the earlier approval or on other data. That cannot be determined from this dataset.

Safety and pharmacovigilance

The records contain no safety information for this product. They list no boxed warning, contraindications, adverse event data, REMS or post-marketing commitments.

As general procedure, an NDA holder in the US must keep to FDA post-marketing requirements. These include adverse event reporting, periodic reporting and good manufacturing practice compliance, which for a gas covers purity, identity and container and closure integrity. The records do not say which of these apply to this product.

What to watch

The approved labeling is the first thing to check. The FDA-approved prescribing information and the approval letter for NDA221805 would show the indication, the conditions of use and any post-marketing requirements. None of these are in the records.

It is also worth checking how the Noble Gas Solutions product relates to the General Air Service & Supply Company product. Labeling, presentation and any differences in scope could matter for commercial or competitive assessment. The records show only that two NDAs exist for a product named Air (air).

Further approvals under the same name, label updates and any FDA safety communications would be the next relevant events. The records show none of these beyond the two approvals listed.