Zydus Cadila gets approval to market unique cancer drug in the US

Zydus is the 'first approved applicant' for Nelarabine Injection which had annual sales of approximately US$ 34.5 million in the United States.

Zydus Cadila has received final approval from the USFDA to market Nelarabine Injection 250MG/50ML in the United States. Zydus Pharmaceuticals USA Inc (Zydus) was granted a Competitive Generic Therapy (CGT) designation for Nelarabine Injection, Single-Dose Vial. 

Zydus is the 'first approved applicant' for Nelarabine Injection. Therefore, with this approval, Zydus is eligible for 180 days of CGT exclusivity for Nelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial.

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

This 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. Nelarabine is in a class of medications called antimetabolites.

Speaking on the development, Sharvil Patel, Managing Director, Cadila Healthcare Ltd said, “This FDA approval of Nelarabine Injection underlines our long-term commitment to patients of 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 filed complex ANDAs and will continue to focus on complex generic products as we continue to explore opportunities to grow our US business.”

At 3.30 PM, Cadila Healthcare closed at Rs 463.15, 1.97 per cent down for the day in BSE on November 18, 2021.