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Zydus Cadila gets tentative US approval for iron excess drug


Zydus Cadila gets tentative US approval for iron excess drug

New Delhi: Drug firm Zydus Cadila said it has got a tentative nod from the US health regulator to market Deferasirox tablets for oral suspension.

“Zydus Cadila has received the tentative approval from USFDA to market Deferasirox Tablets for Oral Suspension (Exjade Tablets) in the strengths of 125 mg, 250 mg, and 500 mg,” the company said in a statement.

The tablet is used to treat 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, wherein blood transfusion is not required — non-transfusion-dependent thalassemia.

The product will be manufactured at the group’s facility at SEZ, Ahmedabad.

The estimated sale os Deferasirox tablets is USD 150.3 million, the statement said.

In line with this, the group now has 202 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04.



Source: PTI
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