Alembic Pharma USFDA tentative approval: Darolutamide Tablets 300mg; $3,155 million market
Alembic Pharmaceuticals Limited has received tentative approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Darolutamide Tablets, 300 mg — a generic equivalent to Bayer HealthCare Pharmaceuticals' branded product Nubeqa Tablets, 300 mg. The approval was announced on May 14, 2026, through a filing with BSE and NSE. Darolutamide is an androgen receptor inhibitor…
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