Home » FDA Denies Insys Petition on Stricter Requirements for Syndros Generics
FDA Denies Insys Petition on Stricter Requirements for Syndros Generics
Drugs Submissions and Approvals
The FDA denied Insys Therapeutics’ petition asking the agency to reject abbreviated new drug applications for generics of Syndros (dronabinol) oral solution that rely on a waiver instead of establishing in vivo bioequivalence.
In March 2017, the agency approved a new drug application for Syndros, a liquid cannabinoid used to treat anorexia in AIDS patients and chemotherapy-induced vomiting. It was the first approved oral solution formulation of the drug.
Insys filed a petition in November claiming a waiver based on equivalence with the parent drug was inappropriate because metabolite equivalence “should be measured in addition to parent drug equivalence.”