RYTARY is an extended-release oral capsule formulation of carbidopa-levodopa. It is not indicated for use in patients using nonselective monoamine oxidase inhibitors (MAO) inhibitors.
The drug contains immediate release and extended-release beads, with a specific amount of carbidopa and levodopa in a 1:4 ratio. It provides both initial and extended levodopa plasma concentrations after a single dose.
Impax Laboratories president and CEO Fred Wilkinson said: "The FDA approval of RYTARY (pronounced rye-TAR-ee) is an important new development for the treatment of Parkinson’s disease and provides an extended-release carbidopa-levodopa product that treats Parkinson’s disease.
"There are approximately one million Americans living with this chronic disease and we are pleased to offer this new therapy as a treatment option for those patients.
"Today’s approval of RYTARY is also a significant milestone for Impax because it is our first branded drug internally developed and approved for commercialization."
In February 2015, the company expects to make available all four strengths of RYTARY 23.75mg/95mg, 36.25mg/145mg, 48.75mg/195mg, and 61.25mg/245mg (carbidopa/levodopa) for commercial distribution.
The RYTARY clinical trial included patients with early (levodopa-naive) to advanced PD in the US and in Europe.