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Zydus Cadila on Saturday announced that it had received final approval from the United States Food and Drug Administration (FDA) to market Decitabine for Injection in the United States.
It has received the US health regulator's nod 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 said in a regulatory filing.
The group now has 326 approvals. It has filed more than 400 ANDAs since the commencement of the filing process in FY 2003-04, it further said.
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