Igalmi

NDA 215390, held by Bioxcel. Dexmedetomidine Hydrochloride.

As of Nov 14, 2026, NDA 215390 (Igalmi), held by Bioxcel, was first approved by FDA on Apr 5, 2022, with 2 approved supplements and 0 published complete response letters.

• First approved: Apr 5, 2022
• Review: Standard
• Supplements approved: 2
• Complete response letters: 0

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