Zydus Cadila gets USFDA nod for cancer drug with 180-days exclusivity

Vivimed Labs | Ramesh Krishnamurthy has resigned from the position of Chief Executive Officer (CEO) & Chief Financial Officer (CFO) of the company.

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 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.

"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.

The company has created a diversified portfolio of more than 50 complex abbreviated new drug applications (ANDAs) and will continue to focus on complex generic products as it continues to explore opportunities to grow US business, he added.

The Zydus group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in 2003-04.