Zydus Cadila Gets 180-Day Exclusivity for Nelarabine Injection, Announces Final Approval from USFDA
November 17, 2021 at 10:56 pm EST
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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. Zydus, in addition to their complex injectable products, has created an industry leading portfolio of difficult to develop oral solids, drug device combinations, topicals, and transdermal patch products. The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in Fiscal Year 2003- 04.
Zydus Lifesciences Limited is an India-based global life sciences company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The Company is engaged in the business of integrated pharmaceutical operations. Its product portfolio includes active pharmaceutical ingredients (API), human formulations, animal health and veterinary, health, and wellness products. Its products include India formulations, Generics and Zydus biologics. The Company's products include Lipaglyn and Bilypsa (Saroglitazar), Ujvira (Trastuzumab emtansine biosimilar), Exemptia (Adalimumab biosimilar), Vivitra (Trastuzumab biosimilar) and Bryxta (Bevacizumab biosimilar). Its Zydus biologics covers various therapeutic areas, such as oncology, autoimmune disease, nephrology, inflammation, rheumatology, hepatology and infectious illnesses, among others. The Company has a global presence and markets its products in the United States, India, Europe and emerging markets.