FDA determines ISTURISA not withdrawn from sale
The FDA has determined that ISTURISA (osilodrostat) tablets, 10 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications for osilodrostat tablets, 10 mg if all other legal and regulatory requirements are met.
Primary source
Federal Register notice, September 30, 2026
Determination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Read the source: Determination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness federalregister.gov
Machine-summarized from the source above; not independently reported. How we use automation