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Cadila Healthcare gets final approval from USFDA for Nelarabine injection

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Cadila Healthcare on Thursday received 180-day exclusivity and a final approval from the USFDA to market nelarabine injection in the United States.

The company said it was granted a Competitive Generic Therapy (CGT) designation for Nelarabine Injection single-dose vial. Cadila said it is the 'first approved applicant' for nelarabine injection and therefore with this approval, it is eligible for 180 days of CGT exclusivity for nelarabine injection.

Nelarabine injection is a chemotherapy drug and used to treat certain types of leukemia and lymphoma by slowing or stopping the growth of cancer cells. Nelarabine is in a class of medications called antimetabolites.

According to IQVIA data (September 2021), nelarabine injection had 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. The drug shall be launched commercially within the US market immediately.

Speaking on the development, Dr. Sharvil Patel, MD of Cadila Healthcare 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.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The company's consolidated net profit surged 534.20% to Rs 3002.30 crore on 3.44% increase in net sales to Rs 3784.80 crore in Q2 FY22 over Q2 FY21.

Shares of Cadila Healthcare ended 1.61% lower at Rs 472.45 on BSE.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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First Published: Thu, November 18 2021. 08:41 IST