The US Food and Drug Administration (FDA) has given final approval to Alembic Pharma’s Abbreviated New Drug Application (ANDA) for Cyclophosphamide capsules, 25 mg and 50 mg. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Cyclophosphamide capsules, 25 mg and 50 mg of Hikma Pharma USA Inc, a statement from Alembic Pharma has notified.
Cyclophosphamide capsules is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic syndrome in pediatric patients, the statement noted.