Zydus Cadila gets USFDA nod for cancer drug with 180-days exclusivity
NEW DELHI: Drug firm Zydus Cadila on Thursday said it has received final approval from the US health regulator to market Nelarabine injection, used to treat certain types of cancer, in the American market with 180-days of marketing exclusivity. The company has received approval from the US Food and Drug Administration (USFDA) for the Nelarabine injection 250 MG/50ML, a generic version of Arranon injection. Zydus Pharmaceuticals USA Inc, a unit of the company, has been granted a competitive generic therapy (CGT) designation for the product and therefore is eligible for 180 days of exclusivity, Zydus Cadila said in a statement. According to IQVIA, Nelarabine injection had annual sales of around USD 34.5 million in the US. The drug is manufactured at the Zydus group's injection manufacturing facility in Ahmedabad and will be launched commercially within the US market immediately. The medication is a chemotherapy drug and is used to treat certain types of leukaemia and lymphoma by ...