Thread: CHMP Recommends Approval of Xadago™ (Safinamide) to Treat Parkinson´s Disease in EU
View Single Post
Old 12-29-2014, 01:18 PM
Tupelo3 Tupelo3 is offline
Member
  
Join Date: Mar 2013
Location: New Jersey
Posts: 832
10 yr Member
Tupelo3 Tupelo3 is offline
Member
 
Join Date: Mar 2013
Location: New Jersey
Posts: 832
10 yr Member
Default update
As a result of file organizational problems, the FDA sent Neuron a Refusal to File (RTA) letter with regard to their initial NDA filing in May. Newron announced today that the NDA for Safinamide has been re-submitted to the FDA. This follows the announcement last week that the CHMP has given a positive opinion on safinamide for Europe. It really is amazing that it takes 6 months for the FDA to reject a submittal and for the company to then resubmit. Just another reason for the unbearable timeline involved in getting a new drug approval.

http://www.cnbc.com/id/102298175
Tupelo3 is offline   Reply With QuoteReply With Quote
"Thanks for this!" says:
anagirl (12-30-2014), lab rat (12-29-2014), Stand Tall (12-30-2014)