India, May 14 -- Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Darolutamide Tablets, 300 mg.
The approved ANDA is therapeutically equivalent to Nubeqa Tablets, 300 mg, marketed by Bayer. Darolutamide is an androgen receptor inhibitor used in the treatment of various forms of prostate cancer, including non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
According to IQVIA data, Darolutamide Tablets, 300 mg, have an estimated market size of USD 3.15 billion for the twelve months ending March 2026.
With this approval, Alembic Pharmaceuticals now has a cumulative total of 238 ANDA...