Drug Approval | August 11, 2024
Granules India receives ANDA approval for Trazodone Tablets
Trazodone tablets are indicated for the treatment of major depressive disorder in adults
Trazodone tablets are indicated for the treatment of major depressive disorder in adults
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
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
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
Q1 Consolidated operating profit Up 8.3%; revenue grows 7% to Rs 3,349 crore
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 acquisition will further strengthen Barentz’ position in India creating a leading life science distribution platform
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