Zydus Cadila gets FDA final approval for Decitabine injection
Zydus Cadila has secured final approval from the US Food and Drug Administration (FDA) for the commercialization of the cancer medication Decitabine for Injection in the strength of 50mg/vial Single-Dose Vial.
Decitabine for Injection is a generic of Dacogen, which is approved for the treatment of myelodysplastic syndromes, some types of blood or bone marrow cancer.
Zydus Cadila said that Decitabine for Injection will be manufactured at its injectables manufacturing plant at Zydus Hospira.
The Indian pharma company has taken its approvals to 326 and to date has filed more than 400 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.