Alembic Pharmaceuticals Limited (Alembic) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Darolutamide Tablets, 300 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nubeqa Tablets, 300 mg, of Bayer HealthCare Pharmaceuticals Inc. (Bayer).
Darolutamide is an androgen receptor inhibitor indicated for the treatment of adult patients with: i) non-metastatic castration-resistant prostate cancer (nmCRPC), ii) metastatic castration-sensitive prostate cancer (mCSPC), and iii) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. Refer to the label for a detailed indication.
Darolutamide Tablets, 300 mg, have an estimated market size of US$ 3,155 million for the twelve months ending March 2026, according to IQVIA.
Alembic has a cumulative total of 238 ANDA approvals (219 final approvals and 19 tentative approvals) from the USFDA.
