FDA OKs Sage ANDA for Generic Apokyn Cartridges

FDA has approved a Sage Chemical ANDA for the first generic version of Mylan’s Apokyn (apomorphine hydrochloride injection) drug cartridges to treat hypomobility “off” episodes (end-of-dose wearing off and unpredictable “on/off” episodes) associated with advanced Parkinson’s disease. FDA notes that the approval is for Sage’s drug cartridges, which must be used with a separately obtained Apokyn Pen. “Patients should first obtain the prescribed Apokyn Pen through a specialty pharmacy before being prescribed the generic apomorphine hydrochloride injection,” it says.

FDA says the most common side effects associated with apomorphine hydrochloride injection are yawning, drowsiness/somnolence, dyskinesias (involuntary muscle movements), dizziness/postural hypotension, rhinorrhea (runny nose), nausea, vomiting, hallucination/confusion, and edema/swelling of extremities.