The U.S. Food and Drug Administration approved Krazati (adagrasib) on December 12, 2022. The approval was recorded under NDA 216340 as an initial application and classified as a Type 1 new molecular entity.
The supplied FDA record identifies BRISTOL as the sponsor. It does not provide an indication, patient population, dosing information, mechanism of action, clinical-trial results, or safety findings.
Background
Adagrasib is listed in the FDA approval record under the brand name Krazati and the generic name adagrasib. The record classifies the application as a Type 1 new molecular entity. No additional drug-class or mechanism details were included in the supplied data.
What this means
The event documents FDA approval of Krazati (adagrasib) through NDA 216340 on December 12, 2022. Because the supplied record does not state the approved indication or population, this event alone does not establish which patients should receive the drug or how it should be used. The data also do not include comparative efficacy, adverse events, or other clinical outcomes.
For verification, the FDA application record is the relevant primary source for the approval event, application classification, sponsor attribution, and date. Additional prescribing or clinical details would require reviewing other FDA documents not included in the supplied data.
Source
Source: FDA, Drugs@FDA application overview for Krazati (adagrasib), NDA 216340, dated December 12, 2022. Available at accessdata.fda.gov.