3 Jul 2025
💊FDA Determines SYNDROS Not Withdrawn, Opens Doors for Generics
Determination That SYNDROS (Dronabinol) Solution, 5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Summary
The Food and Drug Administration (FDA, Agency, or we) has determined that SYNDROS (dronabinol) solution, 5 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SYNDROS (dronabinol) solution, 5 mg/ mL, if all other legal and regulatory requirements are met.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The text indicates that SYNDROS (dronabinol) may have new abbreviated new drug applications (ANDAs) approved, facilitating market entry for generic versions. This can affect pricing strategies, competition, and revenue potential for businesses in the pharmaceutical sector.