Zydus Cadila receives USFDA final approval for Nelarabine Injection

Used in treatment of certain types of leukemia and lymphoma

Zydus Cadila has received final approval from the USFDA to market Nelarabine Injection 250MG/50ML in the United States (US RLD: Arranon).

Zydus Pharmaceuticals USA Inc (Zydus) was granted a Competitive Generic Therapy (CGT) designation for Nelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial. Zydus is the first approved applicant for Nelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial, as defined in section 505(j)(5)(B)(v)(III) of the FD&C Act. 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, under section 505(j)(5)(B)(v) of the FD&C Act.

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, Alidac plant in Ahmedabad and shall be launched commercially within the US market immediately.

This medication 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.

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