Alembic Pharmaceuticals Secures USFDA Nod for Prostate Cancer Drug
Alembic Pharmaceuticals has received tentative approval from the US FDA for its generic Darolutamide tablets, used in prostate cancer treatment. The approval aligns Alembic's tablets with Bayer's Nubeqa, with a market size of USD 3,155 million as of March 2026. This marks an important milestone in cancer medication.
Alembic Pharmaceuticals Ltd has announced that it received tentative approval from the US Food and Drug Administration for its generic Darolutamide tablets. The medication is aimed at treating prostate cancer and presents a significant development in cancer therapy.
The tentative approval covers Alembic's Abbreviated New Drug Application for the tablets, each at a strength of 300 mg, making them therapeutically equivalent to Bayer HealthCare Pharmaceuticals' Nubeqa tablets.
According to Alembic, citing IQVIA data, the market size for Darolutamide 300 mg tablets was estimated at USD 3,155 million for the year ending March 2026.
(With inputs from agencies.)
Advertisement
Google News