Zydus Cadila said it has received tentative regulatory approval from the US Food & Drug Administration for selling Deferasirox, used to chelate or expel excess iron from the blood.
The drug is sold under names such as Exjade, Desirox, Defrijet, Desifer, Rasiroxpine and Jadenu.
Tentative approval means that the company has to wait for all patent and other protections to expire before starting the sale of the drug.
According to IMS, the drug had sales of about $150 mln in the US.
Deferasirox, 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).
The company said the drug will be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad.
With this, said Zydus Cadila, the group now has 202 drug approvals out of the 330 generic drug applications it has filed in the last 15 years.