FDA Determines Ozempic 2 mg/1.5 mL Was Not Withdrawn for Safety or Effectiveness Reasons
In an April 30, 2026 Federal Register notice (docket FDA-2025-P-3849), FDA determined that OZEMPIC (semaglutide) solution, 2 mg/1.5 mL, "was not withdrawn from sale for reasons of safety or effectiveness." Under FDA's rules, this determination allows the agency to continue approving generic drug applications that reference this discontinued Ozempic presentation.
What this meansDeterminations like this are the procedural groundwork for generic semaglutide — a development worth following for anyone weighing brand, generic, or compounded options down the road.
Source: FDA original ↗