FDA approves TAUKLARIFY, new molecular entity from Cerveau Lantheus
The intravenous imaging agent received standard approval under NDA220496, with submission status recorded as of August 13, 2026.
The U.S. Food and Drug Administration approved TAUKLARIFY, an intravenous diagnostic product sponsored by Cerveau Lantheus, under application number NDA220496. The application was classified as a Type 1 New Molecular Entity submission and received standard review priority.1
The product's active ingredient is florquinitau F-18, formulated as a solution with a strength range of 1-40mCi/ML1, administered via the intravenous route.
According to the FDA record, the submission status was listed as AP (approved) with a submission status date of 2026-08-13.1
Supporting application documents filed with the agency include an approval letter dated August 17, 2026, a product label dated August 18, 2026, and a review document (table of contents) dated September 23, 2026, all associated with the original submission for NDA220496.
No additional details on clinical trial data, indications, or company statements were included in the FDA application record reviewed for this report.
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