New Delhi: Drug Firm zydus cadilla On Thursday it has received final approval from the US health regulator to market nelarabine injections used to treat certain types of cancer in the US market with a marketing specification of 180 days.
got approval from the company U.S. Food and Drug Administration ,USFDA) for nelarabine injection 250 MG/50ML, a generic version of Aranon Injection.
A competitive generic therapy has been provided to Zydus Pharmaceuticals USA Inc., a unit of the Company (CGT) designation for the product and is therefore eligible for 180 days of exclusivity, Zydus Cadila said in a statement.
According to IQVIANelarabine injection had annual sales of approximately US$34.5 million in the US.
The drug is manufactured at Zydus Group’s injection manufacturing facility in Ahmedabad and will be commercially launched in the US market immediately.
The drug is a chemotherapy drug and is used to treat certain types of leukemia and lymphoma by slowing or stopping the growth of cancer cells.
“This FDA The approval of nelarabine injection underscores our long-standing commitment to providing patients with access to affordable generics.
“This approval builds on our proven track record of successfully commercializing complex generic products and achieving meaningful market share,” said Sharvil Patel, Managing Director, Cadila Healthcare.
He said the company has built a diversified portfolio of more than 50 complex concise new drug applications (ANDAs) and will continue to focus on complex generic products as it continues to explore opportunities to grow its US business.
The Zydus Group now has 325 approvals and has filed over 400 ANDAs since the filing process began in 2003-04.
got approval from the company U.S. Food and Drug Administration ,USFDA) for nelarabine injection 250 MG/50ML, a generic version of Aranon Injection.
A competitive generic therapy has been provided to Zydus Pharmaceuticals USA Inc., a unit of the Company (CGT) designation for the product and is therefore eligible for 180 days of exclusivity, Zydus Cadila said in a statement.
According to IQVIANelarabine injection had annual sales of approximately US$34.5 million in the US.
The drug is manufactured at Zydus Group’s injection manufacturing facility in Ahmedabad and will be commercially launched in the US market immediately.
The drug is a chemotherapy drug and is used to treat certain types of leukemia and lymphoma by slowing or stopping the growth of cancer cells.
“This FDA The approval of nelarabine injection underscores our long-standing commitment to providing patients with access to affordable generics.
“This approval builds on our proven track record of successfully commercializing complex generic products and achieving meaningful market share,” said Sharvil Patel, Managing Director, Cadila Healthcare.
He said the company has built a diversified portfolio of more than 50 complex concise new drug applications (ANDAs) and will continue to focus on complex generic products as it continues to explore opportunities to grow its US business.
The Zydus Group now has 325 approvals and has filed over 400 ANDAs since the filing process began in 2003-04.
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