Zydus gets 180-day CGT after final approval of Nelarabine injection

Ahmedabad, India: Zydus Cadila received final approval from the US Food and Drug Administration (USFDA) to market nelarabine injection 250mg/50ml, a generic version of Reference Listed Drug Arranon® in the United States. Used in treatment of certain types of leukemia and lymphoma by slowing or stopping the growth of cancer cells.

Zydus was granted a Competitive Generic Therapy (CGT) designation for Nelarabine Injection, to be provided in the capacity of 50 mg/50 mL (5 mg/mL) in a single-dose vial. As Zydus became the “first approved applicant” for the single-dose vial of Nelarabine Injection as defined by the FD&C Act, it is now eligible for 180 days of CGT exclusivity for its Injection.

According to the IQVIA data (September 2021), Nelarabine Injection did annual sales of approximately $34.5 million in the United States. The drug is manufactured at the group’s injection manufacturing facility- Alidac plant in Ahmedabad and shall be launched commercially within the US market immediately.

Classified under the antimetabolites class of medications, the Nelarabine injection is a chemotherapy drug that can be used to treat certain types of leukemia and lymphoma by slowing or stopping the growth of cancer cells.

Speaking about the company’s progress in providing affordable generics, Dr Sharvil Patel, Managing Director, Cadila Healthcare Ltd. said, “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 commercializing and gaining meaningful market share in complex generics products. We have created a diversified portfolio of more than 50 field complex ANDAs and will continue to focus on complex generic products as we continue to explore opportunities to grow our US business.”

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