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FDA News Briefs for Thursday, December 27, 2018

December 27, 2018

These Food and Drug Administration (FDA) developments came in late last week:


FDA Approves New Inhaled Levodopa

Acorda Therapeutics Inc. has announced FDA approval of Inbrija (levodopa inhalation powder; Acorda Therapeutics Inc.) for the intermittent treatment of “off” episodes in patients with Parkinson’s disease treated with carbidopa/levodopa. Inbrija will be distributed in the U.S. through a network of specialty pharmacies. The commercial launch is planned for the first quarter of 2019. More Information.


FDA Approves Long-Acting Complement Inhibitor for Adults with PNH

On December 21, 2018, the FDA approved Ultomiris (ravulizumab-cwvz; Alexion Pharmaceuticals Inc.), an intravenously administered complement inhibitor indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). Ultomiris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). More Information.


FDA Approves First Treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm

Late last Friday, the FDA approved Elzonris (tagraxofusp-erzs; Stemline Therapeutics), an intravenously administered CD123-directed cytotoxin, indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients aged 2 years and older. More Information.