Zydus Receives Tentative Approval from USFDA for Deferasirox Tablets

Zydus Cadila has received the tentative approval from the USFDA to market Deferasirox Tablets for Oral Suspension (Exjade Tablets) in the strengths of 125 mg, 250 mg, and 500 mg. It is 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 will be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad. The estimated sale for Deferasirox Tablets is USD 150.3 million (Source: IMS Health, IMS National Sales Perspective Audit, MAT May 2018, extracted June 2018.) In line with this, the group now has 202 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04. – Medical Buyer Bureau

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