Alembic Pharma announces USFDA Tentative Approval for Darolutamide Tablets
Ahmedabad, 16th May: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received 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…
