Alembic Pharma Steps Closer To US Oncology Market With Darolutamide Nod

Ashik Bothra May 14, 2026 370 Views

Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its generic Darolutamide tablets, 300 mg, used in the treatment of prostate cancer. The approval moves the company a step closer to entering a high-value oncology segment in the US, pending final launch clearance linked to patents and market exclusivity.