Specialty pharmaceutical company US WorldMeds has asked the FDA to require that generic competitors for its treatment for advanced Parkinson’s disease get approval for both the medication and the medical device components of the injectable.
The company’s approved combination product Apokyn consists of a multi-dose glass cartridge containing 10 mg of apomorphine hydrochloride solution and a multi-dose pen injector.
Both the drug and the device were approved in the NDA and the company argues that any abbreviated new drug application for a generic version should seek approval of both the drug and device constituent parts.
The device design is “critical” to ensuring safe and effective use of the drug, the company writes in a citizen petition filed July 1. Since no alternative devices exist, an ANDA that does not include its own device constituent part would be proposing the use of the Apokyn pen, which would be an “improper” use, the company says.