Alembic Pharmaceuticals receives USFDA approval for Darolutamide Tablets, 300 mg

Alembic Pharmaceuticals (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) 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 label for a detailed indication.