Drug Approval | August 25, 2024
BI Sky Global successfully completes FDA MoCRA registration
MoCRA mandates that all facilities involved in the manufacturing and processing of cosmetic products for sale in the United States
MoCRA mandates that all facilities involved in the manufacturing and processing of cosmetic products for sale in the United States
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older
Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients
Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.
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
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)
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
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