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Surprise Knockback For Safinamide Gives Azilect A Boost

This article was originally published in Scrip

Executive Summary

Just days after US WorldMeds signed up to commercialize the Parkinson's disease add-on therapy Xadago (safinamide) in the US, with US approval anticipated on its Mar. 29 PDUFA date, the product has been turned back by the FDA. The agency wants evaluation of the oral, once a day drug for its abuse liability and dependence/withdrawal effects before it can be approved, it said in a complete response letter.

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