Alembic Pharmaceuticals gets FDA nod for Deferasirox tablets

India’s Alembic Pharmaceuticals announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Deferasirox tablets, 180 mg.

The drug, used to treat hereditary haemolytic diseases caused by faulty haemoglobin synthesis, is therapeutically equivalent to the reference listed drug product (RLD), Jadenu tablets, 180 mg, of Novartis Pharmaceuticals Corporation (Novartis).

Deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions and for treatment of chronic iron overload in non-transfusion-dependent Thalassemia (NTDT) syndrome patients.

NTDT are primarily to be found in the low- or middle-income nations of the tropical belt stretching from sub-Saharan Africa, through the Mediterranean region and the Middle East, to South and Southeast Asia.

Consanguineous Marriages

This is due to the high frequency of consanguineous marriages in these regions, as well as to a conferred resistance of carriers to severe forms of malaria in regions where the infection has been, or is still, prevalent.

Increasing incidences of these disorders in other parts of the world, such as North Europe and North America, previously relatively unaffected by these conditions, have also been reported.

Alembic had previously received final approval for Deferasirox tablets, 90 mg and 360 mg and tentative approval for Deferasirox tablets, for 180 mg. Deferasirox tablets, 180 mg have an estimated market size of US$ 53 million for twelve months ending March 2020 according to U.S.-research company, IQVIA.

Alembic now has a total of 122 ANDA approvals (109 final approvals and 13 tentative approvals) from USFDA.

Make and Market

An abbreviated new drug application contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower-cost alternative to the brand-name drug it references.

Alembic Pharmaceuticals is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

Alembic is one of the leaders in branded generics in India. Alembic’s brands, marketed through a marketing team of more than 5,000 are well recognized by doctors and patients.