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As of Nov 14, 2026, NDA 214826 (Loreev Xr), held by Almatica, was first approved by FDA on Aug 27, 2021, with 2 approved supplements and 0 published complete response letters.
First approved: Aug 27, 2021
Review: Standard
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
LOREEV XR is indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets.
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
