FDA-NDA219627
Document details
Summary
Ambelvist (Gadoquatrane) is approved for intravenous administration, indicating that billing will follow the Part B pathway. As it is designated as an orphan drug, it may qualify for special consideraNew orphan drug Ambelvist approved for intravenous administration.
Affected specialty
Radiology alerts →Source document
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219627CLV Intelligence summarizes publicly available federal publications. Not affiliated with or endorsed by any government agency.
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