Zydus Cadila obtains FDA green light for generic Jadenu

Levy

Patients with iron overload caused by certain conditions will soon have a new generic drug treatment.

The Food and Drug Administration has cleared Zydus Cadila’s deferasirox tablets in dosage strengths of 90 mg, 180 mg and 360 mg.

The product is the generic of Novartis’ Jadenu tablets.

Deferasirox binds to iron and removes it from the bloodstream. It is used to treat iron overload caused by blood transfusions in adults and children who are at least 2 years old. It is also used to treat chronic iron overload syndrome caused by a genetic blood disorder (non-transfusion dependent thalassemia) in adults and children who are at least 10 years old.

The drug will be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad.

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