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.
the paid sections dig into the full 2017-2026 FDA milestone timeline, the 503A vs 503B compounding distinction, the salt-form litigation that drove the shortage delisting, and how international pricing and generic timelines diverge from the US landscape.
Interactive Visualization
trace the timeline of FDA approvals, shortage declarations, compounding enforcement actions, and key legal decisions.