USFDA grants Zydus Cadila 180-day exclusivity for Nelarabine injection

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The United States Food and Drug Administration (FDA) has issued final approval to Zydus Cadila to market Nelarabine injection 250MG/50ML in the United States, an official statement released by the company said.

Nelarabine is a chemotherapy drug and 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, Dr 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 commercialising and gaining meaningful market share in complex generics products,” he added.

“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,” Dr Patel informed.


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