The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia
The product is bioequivalent and therapeutically equivalent to the reference listed drug
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
The approved ANDA is therapeutically equivalent to the reference listed drug product
Sacubitril and Valsartan combination is used to treat chronic heart failure in adults
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