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Sold as Tzield. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Teplizumab-Mzwv (sold as Tzield), first approved Nov 17, 2022, with 2 new uses approved and 1 published complete response letter.
First approved: Nov 17, 2022
Applications: 1
New uses approved: 2
Complete response letters: 1
Medicare spending, 2025: $1.3M
Orphan exclusivity until: Jun 12, 2033
First approved in the EU: Jan 8, 2026
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA