14th November, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cyclophosphamide Capsules, 25 mg and 50 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cyclophosphamide Capsules, 25 mg and 50 mg of Hikma Pharmaceuticals USA Inc. Cyclophosphamide Capsules is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic syndrome in pediatric patients. Refer to our label for full indication.
Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.
Alembic has a cumulative total of 176 ANDA approvals (152 final approvals and 24 tentative approvals) from USFDA.