Persion Pharmaceuticals has petitioned the FDA to ensure that generics of its Zohydro ER hydrocodone bitartrate extended-release capsules prove their bioequivalence in patients with hepatic impairment.
The drugmaker claims that generic formulations of hydrocodone bitartrate ER “pose serious and potentially life-threatening safety risks” in patients with mild or moderate hepatic impairment, particularly if the generic forms have not demonstrated the same safety performance as Zohydro ER in this patient population.
Persion wants the agency to require all new and pending ANDAs for generic hydrocodone bitartrate ER to provide data on bioequivalence to Zohydro ER in patients with hepatic impairment prior to granting approval. Currently, the FDA only recommends bioequivalence testing in healthy subjects.
