Zydus Cadila on Thursday said it has received final approval from the U.S. Food and Drug Administration (USFDA) to market Nelarabine Injection 250MG/50ML, in the US with 180 days of marketing exclusivity.
The drugmaker said it is the first approved applicant for the product, which is generic version of Arranon. A chemotherapy drug, the product is used to treat certain types of leukaemia and lymphoma by slowing or stopping the growth of cancer cells. Nelarabine is in a class of medications called antimetabolites.
Nelarabine Injection had annual sales of approximately $34.5 million in the U.S., the company said citing IQVIA data (September 2021). The drug is manufactured at the group’s injection manufacturing facility, Alidac plant in Ahmedabad, and will be launched commercially in the U.S. market immediately.
Cadila Healthcare Managing Director Sharvil Patel, in a release, said “this approval builds on our proven track-record of successfully commercialising and gaining meaningful market share in complex generics products. We have created a diversified portfolio of more than 50 filed complex ANDAs and will continue to focus on complex generic products as we continue to explore opportunities to grow our U.S. business.”