Drug Approval | August 11, 2024
Zydus receives final approval from USFDA for Valbenazine Capsules
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
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
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
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
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
The inspection was concluded with two 483 observations
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
Subscribe To Our Newsletter & Stay Updated
