Drug Approval | September 19, 2024
Lupin receives USFDA approval for Bumetanide Injection
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
The new facility further improves the operational efficiency and readies the site for the completion of the new large-scale production plant
ForDoz Pharma Corporation, USA (ForDoz) received an approval for its ANDA from the USFDA
The approval further adds to Biocon’s portfolio of complex drug products
Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
Cyclosporine Ophthalmic Nanoemulsion is a preservative-free Nanoemulsion that has been approved in South Korea, Peru and several countries in the Middle East for treatment of dry eye syndrome
Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness
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