BioCentury
ARTICLE | Clinical News

Neupro rotigotine regulatory update

January 7, 2013 8:00 AM UTC

On Dec. 25, 2012, partner Otsuka said Japan's Ministry of Health, Labor and Welfare (MHLW) approved an NDA for the room-temperature stable formulation of transdermal Neupro rotigotine to treat Parkinson's disease and symptoms of moderate to severe idiopathic restless legs syndrome (RLS) in adults. The pharma plans to launch Neupro in Japan in 1Q13. Otsuka has exclusive, Japanese rights to the once-daily dopamine D2 receptor agonist under a 2002 deal with Schwartz Pharma AG, which UCB acquired. UCB has development and commercialization rights in all other regions worldwide. ...