FDA approves supplement for NUVATION's Ibtrozi (NDA219713)

The FDA approved a supplement, numbered 4, for IBTROZI under application NDA219713, with sponsor listed as NUVATION.¹ The submission was classified as an efficacy supplement.

IBTROZI is an oral capsule containing taletrectinib adipate at a strength equivalent to 200 mg base.¹

The submission carried a standard review priority.¹ FDA records list the submission status as AP (approved) with a submission status date of September 16, 2026.¹

Application documents tied to this action include an approval letter dated September 21, 2026, and an updated product label dated September 22, 2026.¹ Both documents are posted on the FDA's Drugs@FDA site under application number 219713.

The record does not specify what change or new data prompted this particular efficacy supplement, nor does it describe any new indication, dosing change, or trial results tied to the approval. Readers seeking those specifics should consult the linked approval letter and label directly, as the database entry itself contains only administrative and regulatory metadata.