Zydus Cadila secures USFDA okay for Nelarabine Injection in US
Ahmedabad: Drugmaker, Zydus Cadila, today announced that the company has received final approval from the United States Food and Drug Administration (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.
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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