FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT ISTURISA (OSILODROSTAT) TABLETS, 10 MILLIGRAMS, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, Sept. 30 -- Food and Drug Administration has issued a notice called: Determination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on Sept. 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) has determined that ISTURISA (osilodrostat) tablets, 10 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for osilodrostat tablets, 10 mg if all other legal and regulatory requirements are met....