USA – Generic drugmakers get cannabidiol bioequivalence guidance from FDA

Manufacturers who seek to produce generic versions of cannabidiol oral solution received guidance from the US Food and Drug Administration (FDA) on establishing bioequivalence with the reference listed drug.
 
The guidance follows the June 2018 approval of Epidiolex (cannabidiol) oral solution to treat seizures associated with two rare and serious types of childhood epilepsy. Epidiolex was also approved to treat a third seizure condition, tuberous sclerosis complex, in July 2020. (RELATED: Update on the regulatory status of cannabidiol in food and dietary supplements and future prospects, Regulatory Focus 12 June 2019)
 
Generic versions of cannabidiol oral solution 100 mg/ml must have “the same active drug ingredient in the same concentration and dosage form as the reference listed drug” in order to qualify for a waiver that exempts the drugmaker from conducting the otherwise-required in vivo bioequivalence study…