New Delhi: Drug firm Zydus Cadiz Tuesday said it has received the tentative nod from the US health regulator to market generic Deferasirox tablets used to treat high iron levels in the body. The company has received the tentative approval from the United States Food and Drug Administration (USFDA) to market Deferasirox tablets in the strengths of 90 mg, 180 mg, and 360 mg, Zydus Cadila said in a statement.
The product will be manufactured at the group’s formulations manufacturing facility at special economic zone (SEZ) in Ahmedabad, it added.
The tablets are used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions (non-transfusion dependent thalassemia), it said.
The group has now 231 approvals and has so far filed over 340 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added.