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# FDA Grants Octapharma Orphan Status for Octagam Indication
- URL: https://www.fdaweb.com/fda-grants-octapharma-orphan-status-for-octagam-indication/
- Published: 2017-05-19T12:00:00.000Z
- Updated: 2026-09-14T22:24:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138740

FDA has granted Octapharma USA an orphan drug designation for Octagam \[immune globulin intravenous (human) 10% liquid\] for treating dermatomyositis, a rare acquired disorder characterized by chronic inflammatory and degenerative changes of the muscles and skin. Octagam is currently approved for treating chronic immune thrombocytopenic purpura (ITP) in adults. It carries labeled warnings on thrombosis, renal dysfunction and acute renal failure.