Zydus Cadila gets USFDA nod for cancer drug Nelarabine 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 slowing or stopping the growth of cancer cells.

"This FDA approval of Nelarabine Injection underlines our long-term commitment to patients by providing them access to affordable generics. This approval builds on our proven track record of successfully commercialising and gaining meaningful market share in complex generics products," Cadila Healthcare Managing Director Sharvil Patel said.