The FDA approved a supplemental application for Tagrisso (osimertinib) on December 18, 2020, according to the agency’s drug-approval record. The entry classifies the supplement as an efficacy application but does not state the specific indication or describe supporting clinical data.
Background
The record identifies osimertinib, also known by the brand name Tagrisso, and classifies the supplemental application as “Efficacy.” It does not provide the drug’s class, mechanism, indication, or information about prior approvals. The approval event is identified as a supplemental application associated with NDA 208065.
What this means
The FDA record confirms that the agency approved an efficacy-related supplemental application for osimertinib on the listed date. However, the supplied entry does not identify what specific use or population the supplement covered, explain what evidence supported the decision, or provide trial results. Those details cannot be established from this record alone; the approval should not be interpreted as a particular new indication based only on the information supplied here.
Source
Source: U.S. Food and Drug Administration (FDA), Drug Approval Package database record for NDA 208065, dated December 18, 2020. Available at accessdata.fda.gov.