Alembic Pharmaceuticals on Tuesday announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Deferasirox Tablets, 180 mg.
In a regulatory filing, the company said that the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jadenu Tablets, 180 mg, of Novartis Pharmaceuticals Corporation (Novartis).
Deferasirox tablets are indicated for treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) and for treatment of Chronic Iron
Overload in Non-Transfusion-Dependent Thalassemia Syndromes.
Alembic had previously received final approval for Deferasirox Tablets, 90 mg and 360 mg and tentative approval for Deferasirox Tablets, for 180 mg. Alembic now has a total of 122 ANDA approvals (109 final approvals and 13tentative approvals) from USFDA.
Deferasirox Tablets, 180 mg have an estimated market size of US$ 53 million for twelve months ending March 2020 according to IQVIA.