FDA label
What is bicalutamide used for?
The FDA-approved uses of bicalutamide, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.”
Run it in Rivvi
Which 2027 plans near you dropped or restricted bicalutamide?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Bicalutamide, tablet
Indications and Usage, quoted from the label by Viona Pharmaceuticals Inc. (ANDA079089). Cross-references to other label sections are left out.
Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments.
Source: DailyMed label, set id 5a7cbe80-f119-4b3d-949a-c7824ea91908, version 1, effective August 19, 2025. NDC 72578-215, one of 5 listings for this product.
Questions
What is bicalutamide used for?
The FDA label says: “Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.”
What drug class is bicalutamide?
FDA lists bicalutamide in the Androgen Receptor Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.