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Treats severe frostbite. NDA 217933, held by Btg Intl. Iloprost.
As of Nov 14, 2026, NDA 217933 (Aurlumyn), held by Btg Intl, was first approved by FDA on Feb 13, 2024, with 1 approved supplement and 0 published complete response letters.
First approved: Feb 13, 2024
Review: Priority
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
AURLUMYN is a prostacyclin mimetic indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes. 1.1 Frostbite
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