Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
For the 2024 outlook, sales growth is now expected to be 22-28% at CER
The inspection was concluded with zero observations
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
Trazodone tablets are indicated for the treatment of major depressive disorder in adults
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
The approved product has an estimated market size of US$ 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
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