Zydus Cadila receives final approval from US FDA for Decitabine injection

Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market Decitabine for injection in the strength of 50 mg/vial Single-Dose Vial (USRLD: Dacogen). 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 at Zydus Hospira, the company notified via a statement.

The group now has 326 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04, it added.