Barrier Therapeutics To Submit Amended J&J Miconazole Diaper Rash NDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Barrier plans to submit the application by year-end, seeking a narrower indication than the original Johnson & Johnson NDA. Barrier's Phase III study of Zimycan in Candida-associated diaper dermatitis was designed to address FDA concerns over the scope and definition of the non-specific diaper dermatitis indication J&J had pursued for the ointment, then called Pediastat.
You may also be interested in...
PTC’s Upstaza Takes Gene Therapy Straight To Brain (And US FDA); Translarna To Return Mid-Year
In a year full of regulatory milestones for the firm, PTC Therapeutics hopes to set some approval precedents – and basically hopes its candidates have an easier time of it than they have had before.
BeiGene’s Tevimbra And The End Of The COVID Inspection Era
US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.
Novo Nordisk’s Semaglutide Achieves ‘Cardiodiabesity’ Label
With Wegovy’s new indication for cardiovascular risk reduction in patients with overweight and obesity, the migration of diabetes drugs from a single disease state to address a host of interrelated conditions reaches a new milestone.