Zydus Cadila, part of Cadila Healthcare group, on Tuesday said it has received final approval from the US health regulator to market its generic version of Deferasirox tablets used in treatment of chronic iron overload due to blood transfusions.
The approval by the US Food and Drug Administration (USFDA) for Deferasirox tablets is for multiple strengths of 90 mg, 180 mg and 360 mg, Cadila Healthcare said in a regulatory filing.
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 two 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 company said.
"The drug will be manufactured at the group's manufacturing facility at special economic zone, Ahmedabad," it added.
The group now has 291 approvals and has so far filed over 390 abbreviated new drug applications since the commencement of the filing process in FY 2003-04.