30 May 2025
💊FDA Confirms ACTIGALL Not Withdrawn, Opens Market for Generics
Determination That ACTIGALL (Ursodiol) Capsule, 150 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Summary
The Food and Drug Administration (FDA or Agency) has determined that ACTIGALL (ursodiol) capsule, 150 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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 ursodiol capsule, 150 mg, if all other legal and regulatory requirements are met.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The notice confirms that ACTIGALL (ursodiol) is not withdrawn for safety or effectiveness, enabling the approval of generic drug applications. This impacts pharmaceutical companies looking to enter the market with generic versions, fostering competition and potentially reducing costs.