The FDA approved Tagrisso (osimertinib) on November 13, 2015, according to the agency’s drug-approval record. The record classifies the application as a new molecular entity and identifies AstraZeneca as the sponsor; it does not state the approved indication or provide clinical outcome data.
Background
The supplied FDA record identifies osimertinib, also known by the brand name Tagrisso, and classifies the product as a Type 1 new molecular entity. It does not describe the drug’s class, mechanism, intended patient population, or the condition for which it was approved. No prior approval history or disease-prevalence information is included in the supplied data.
The approval entry is associated with New Drug Application 208065. The record’s headline says the FDA approved Tagrisso (osimertinib), while its summary names AstraZeneca as sponsor. The supplied information does not include labeling details, the review rationale, or the evidence considered by the agency.
What this means
The event establishes that the FDA approved osimertinib on November 13, 2015, and that the agency’s record categorized it as a new molecular entity. However, this data block does not identify the indication, patient eligibility, dosing, safety findings, or efficacy results. Those details cannot be inferred from the approval headline or classification alone. Clinicians and researchers seeking to assess how the approval affects treatment decisions would need to consult the FDA’s associated application materials and labeling; the supplied record does not provide their contents.
Source
Source: U.S. Food and Drug Administration (FDA), Drug Approval Overview record for Tagrisso (osimertinib), application NDA 208065, dated November 13, 2015. Available at accessdata.fda.gov.