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www.fdanews.com/articles/174686-actelion-to-launch-uptravi-in-early-january

Actelion to Launch Uptravi in Early January

December 30, 2015

Following a sign off from the FDA, Actelion plans to bring its pulmonary arterial hypertension drug Uptravi to market in early January.

Actelion, which acquired the compound from Nippon Shinyaku, also is pursuing approval for Uptravi in Australia, Canada, New Zealand, South Korea, Switzerland and Taiwan. Actelion is responsible for global development and commercialization of selexipag outside Japan. The two companies will co-develop and co-commercialize in Japan, and Nippon Shinyaku will receive milestone payments based on development and sales milestones.

Uptravi had been granted orphan drug designation, making it eligible for exclusivity, tax credits and user fee waivers.