Zydus Cadila gets USFDA nod to market generic drug

Drug firm Zydus Cadila on Thursday said it has received approval from the US health regulator to market Deferasirox tablets for oral suspension, used to treat high levels of iron in people with a certain blood disorder, in the the American market.

The company has received approval for the product from the US Food and Drug Administration (USFDA) in strengths of 125 mg, 250 mg and 500 mg, Zydus Cadila said in a statement.

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 drug will be manufactured at the Zydus group's Ahmedabad-based manufacturing facility.

The company said it now has 289 approvals and has so far filed over 386 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04.