Bartek's Apokyn cleared by FDA

USA-based Bertek Pharmaceuticals, a subsidiary of Mylan Laboratories, has received approval from the US Food and Drug Administration for Apokyn (apomorphine hydrochloride injection). The agent is cleared for the acute, intermittent treatment of hypomobility episodes associated with advanced Parkinson's disease - the so-called "off periods" - when subjects become immobile and can no longer perform activities of daily living.

The injectable apomorphine hydrochloride formulation was licensed by Bertek in 1999 from the UK's Britannia Pharmaceuticals. Under the terms of the deal, Bertek acquired the US rights to the product. Marketed under the trade name Apo-go, apomorphine is registered for use in eight European countries, including the UK.