To co-develop and co-commercialize MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager, worldwide except for Japan where Merck retains exclusive rights
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
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
Campaign launched to spread awareness regarding dengue prevention and control
The inspection was concluded with two 483 observations
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
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
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