Drug firm Zydus Cadila on Saturday said it has received approval from the US health regulator to market Decitabine injection, used to treat certain types of cancers, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to Decitabine for Injection in the strength of 50 mg/vial single-dose vial, Zydus Cadila said in a statement.
Decitabine is used to treat myelodysplastic syndromes, certain types of blood or bone marrow cancer. The drug will be manufactured at the group’s injectables manufacturing facility, the drug maker said.
The Zydus group now has 326 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04, it added.