Costa Mesa-based Valeant Pharmaceuticals International said Tuesday it got an “approvable letter” from the Food and Drug Administration for Zelapar, a drug to treat Parkinson’s disease.
An approvable letter comes after a drug company’s marketing application is in order but other issues need to be resolved before regulators give a final signoff for the drug.
Valeant, in a statement, said that it would meet with the FDA to clarify issues it previously addressed with the agency, but didn’t give specifics.
Valeant received the rights to Zelapar in 2004, when it spent $38 million to buy the American drug unit of London-based Amarin Corp. That deal calls for Valeant to pay $8 million to Amarin upon FDA approval to Zelapar and then pay $10 million after certain sales goals are reached.
