The company has received final approval from the USFDA to market its product which is a generic version of Gleevec tablets, Zydus Cadila said in a statement
Drugmaker Zydus Cadila on Thursday said it has received final nod from the US health regulator to market Imatinib Mesylate tablets used for the treatment of certain type of cancers.
The company has received final approval from the US Food and Drug Administration (USFDA) to market its product which is a generic version of Gleevec tablets, Zydus Cadila said in a statement.
The Ahmedabad-based firm has received approval to market the drug in strengths of 100 mg and 400 mg, it added.
"This medication is used to treat certain types of leukaemia (blood cancer), bone marrow disorders, skin cancer and tumours of the stomach and digestive system," the drugmaker said.
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, in Ahmedabad.
The company said it now has 285 approvals and has so far filed over 386 abbreviated new drug application (ANDAs) since the commencement of the filing process in 2003-04.Time to show-off your poker skills and win Rs.25 lakhs with no investment. Register Now!
