Zydus Cadila gets USFDA nod to market generic cancer drugPTI | New Delhi | Updated: 09-04-2020 12:51 IST | Created: 09-04-2020 12:51 IST
New Delhi, Apr 9 (PTI) Drug maker Zydus Cadila on Thursday said it has received final nod from the US health regulator to market Imatinib Mesylate tablets used for 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 leukemia (blood cancer), bone marrow disorders, skin cancer and tumors of the stomach and digestive system," the drug maker 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 abbriviated new drug application (ANDAs) since the commencement of the filing process in 2003-04.