Zydus Cadila receives tentative approval from USFDA for Deferasirox Tablets

09 Jul 2018 Evaluate

Zydus Cadila has received the tentative approval from the US Food and Drug Administration (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. It will be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad. The estimated sale for Deferasirox Tablets is $ 150.3 million.

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.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

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