Zydus Cadila said it has received approval from the US health regulator to market Arsenic Trioxide injection, used to treat a type of leukemia.
Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Arsenic Trioxide injection, 10 mg/10 mL (1 mg/mL) single-dose vial, the company said in a BSE filing.
Arsenic Trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL) when other types of treatment (such as chemotherapy) have not worked well or no longer work, it added.
Zydus Cadila said the drug will be manufactured at Alidac Pharmaceuticals, the company’s wholly-owned subsidiary located at special economic zone (SEZ), Ahmedabad.
The group has more than 228 approvals, and so far filed over 330 abbreviated new drug applications (ANDAs) since it started filings in 2003-04.