Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

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.