FDA approves Zydus Cadila's generic Exjade

The Food and Drug Administration has cleared Zydus Cadila’s deferasirox tablets for oral suspension. The product is the generic of Novartis’ Exjade tablets for oral suspension.

Zydus Cadila’s product is available in dosage strengths of 125 mg, 250 mg and 500 mg.

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 also is 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.