FDA approves AbbVie's tavapadon tablets under brand name Juvmo
The new molecular entity application for tavapadon, submitted by AbbVie, received FDA approval dated September 25, 2026.
The FDA approved AbbVie's application for Juvmo (tavapadon), according to an FDA Drugs@FDA record for application number NDA220415. The filing is listed as an original, type 1 submission for a new molecular entity, with sponsor AbbVie Inc.1
The approval covers an oral tablet formulation of tavapadon available in five strengths: 0.25 mg, 1 mg, 5 mg, 10 mg, and 15 mg.1
The FDA record lists the submission status as "AP," indicating approval, with a submission status date of 2026-09-25.1 The review was classified as standard priority rather than priority review, according to the record.
An approval letter tied to the application is dated September 29, 2026, according to the application documents listed in the FDA record, which cites a letter filed with ID 87314.1
The record does not specify the approved indication, dosing regimen, or clinical trial data supporting the approval. No additional details on pricing, launch timing, or commercial plans were included in the filing reviewed for this report.
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