Zydus Cadila gets final USFDA approval:

Zydus Wellness

Zydus Cadila has received final approval from the USFDA to market Nelarabine Injection 250MG/50ML in the United States. 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, company said in the release.

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, it added.

Cadila Healthcare was quoting at Rs 473.25, up Rs 0.80, or 0.17 percent.

News Source:- Moneycontrol

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