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Treats Stage D 2 metastatic carcinoma of the prostate. Sold as Casodex. Every FDA application for this active ingredient: 2 branded and 13 generic.
As of Nov 13, 2026, FDA lists 15 applications for Bicalutamide (sold as Casodex), first approved Oct 4, 1995, with 1 new use approved and 0 published complete response letters.
First approved: Oct 4, 1995
Applications: 15
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $7.5M
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Product
Part
Spending, 2025
Change
Beneficiaries
Bicalutamide
Part D
$7.3M
+8%
70,977
Casodex
Part D
$202K
-15%
12
Clinical Trials
46 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
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
Astrazeneca
Teva
Sandoz
Apotex