The announcement follows the FDA’s peripheral and central nervous system drugs advisory committee’s unanimous decision in December 2007 to recommend Xenazine for approval.
Cambridge owns the worldwide rights to Xenazine and licensed the US and Canadian rights to Prestwick Pharmaceuticals in 2002 and 2004 respectively. The drug is marketed as Nitoman in Canada and is approved for the treatment of various hyperkinetic movement disorders, including chorea associated with Huntington’s disease.
Xenazine will be distributed in the US by Cambridge’s partner Prestwick Pharmaceuticals.
Mark Evans, CEO of Cambridge Laboratories, said: “We look forward to working with our marketing partner Prestwick to drive Xenazine’s success as it enters the key US market place.”