Drug company Zydus Cadila said on Saturday it has received approval from the U.S. health regulator to bring the Decitabine injection, which is used to treat certain types of cancer, to the U.S. market.
The company has received final approval from the United States Food and Drug Administration (USFDA) for Decitabine for Injection in the single-use 50 mg/vial strength, 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 drugmaker said.
The Zydus group now has 326 approvals and has submitted more than 400 abridged new drug applications (ANDAs) to date since the filing process began in 2003-04, it added.