News | August 06, 2024
Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA
Revolutionary technology will further boost OneSource’s scientific services offerings
Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia
More emphasis should be given on investing healthcare resources towards prevention of diseases rather than only focusing on diagnostic and therapeutic options
This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries
The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo
The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2
Boehringer Ingelheim aims to develop this program as a potential key centerpiece component for its immuno-oncology portfolio
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