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Treats OFF episodes. NDA 209184, held by Merz. Levodopa.
As of Nov 13, 2026, NDA 209184 (Inbrija), held by Merz, was first approved by FDA on Dec 21, 2018, with 5 approved supplements and 0 published complete response letters.
First approved: Dec 21, 2018
Review: Standard
Supplements approved: 5
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
