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
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia
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 inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
The inspection was concluded with two 483 observations
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
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
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