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Alembic Pharma secures USFDA tentative nod for generic Darolutamide prostate cancer tablets
Business
Published on 14 May 2026
The nod covers a specific 300 mg strength
Alembic Pharmaceuticals has received USFDA tentative approval for its generic Darolutamide tablets used in prostate cancer treatment. The approval applies to the 300 mg strength, positioning Alembic’s product as a generic equivalent to Nubeqa Tablets. With significant demand expected for this category, the company could gain momentum as it moves toward final commercialization.
- USFDA granted tentative approval to Alembic’s generic Darolutamide
- Approval is for the 300 mg tablet strength
- The drug is a generic version of Nubeqa Tablets
- Market demand could support Alembic’s growth outlook
Read the full story at The Economic Times
This summarization was done by Beige for a story published on 
The Economic Times