Costa Mesa-based Valeant Pharmaceuticals International said Thursday that the Food and Drug Administration approved Zelapar, a pill to use in combination with others to treat Parkinson’s disease.
Zelapar will be used as an additional treatment for patients who use the standard drug cocktail of levodopa and carbidopa for Parkinson’s, but are showing a deteriorating response to that combination.
Zelapar is a tablet that quickly dissolves in a patient’s mouth and delivers more of an active ingredient at a smaller dose.
Valeant had received an approvable letter from regulators for Zelapar in October. But the FDA asked for additional data before it signed off on the treatment.
The drug maker acquired Zelapar in 2004, when it bought the U.S. drug business of London’s Amarin Corp.
Under that deal, Valeant agreed to pay Amarin $8 million upon approval of Zelapar, and then $10 million after certain sales milestones were reached.
Valeant shares were unchanged in midday trading Thursday.
