regulatory landscape and compounding
FDA approvals, compounding controversy, salt form issues, and global access
regulatory landscape and compounding
semaglutide sits at the center of one of the most contentious regulatory battles in modern pharmaceutical history. the FDA approval pathway spanned diabetes (Ozempic, 2017), obesity (Wegovy, 2021), and cardiovascular risk reduction (2024), while compounding pharmacies exploited shortage designations to produce versions outside Novo Nordisk's patent umbrella. the salt form question -- whether semaglutide sodium qualifies as the same active ingredient -- became the legal fulcrum.
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Interactive Visualization
trace the timeline of FDA approvals, shortage declarations, compounding enforcement actions, and key legal decisions.