Home Menu

Site Navigation



Parkinson's Disease Tulip


advertisement
NeuroTalk Support Groups > > >

When Will Xadago Be Approved?

Reply
 
Thread Tools Display Modes
Old 02-27-2017, 08:47 PM #1
Blackfeather Blackfeather is offline
Member
  
Join Date: Jun 2014
Posts: 175
8 yr Member
Blackfeather Blackfeather is offline
Member
 
Join Date: Jun 2014
Posts: 175
8 yr Member
Default When Will Xadago Be Approved?
Does anyone on this forum have any info on if and when Xadago might be approved for U.S. market? Also known as safinamide. It's availaable in Europe and seems effective and well tolerated.
Blackfeather is offline   Reply With QuoteReply With Quote
"Thanks for this!" says:
curem (03-26-2017)

advertisement
Old 02-27-2017, 10:39 PM #2
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
Quote:
Originally Posted by Blackfeather View Post
Does anyone on this forum have any info on if and when Xadago might be approved for U.S. market? Also known as safinamide. It's availaable in Europe and seems effective and well tolerated.
After several years and multiple rejections on their NDA submissions, the safinamide filing was accepted by the FDA on Oct 21 2016. Newton and partners also received 6 month expedited review, rather than the normal 10 months. So, Their PDUFA will be March 21st.
Tupelo3 is offline   Reply With QuoteReply With Quote
"Thanks for this!" says:
Blackfeather (02-28-2017), jeffreyn (02-27-2017)
Old 03-21-2017, 07:00 PM #3
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 FDA Approval
Right on schedule!
Tupelo3 is offline   Reply With QuoteReply With Quote
"Thanks for this!" says:
anagirl (03-21-2017), eds195 (03-21-2017), jeffreyn (03-21-2017)
Reply

Tags
approved, availaable, safinamide, tolerated, xadago

« Previous Thread | Next Thread »

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts
BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Similar Threads
Thread Thread Starter Forum Replies Last Post
Starting Xadago® sim00 Parkinson's Disease 12 12-03-2018 09:46 PM
CHMP Recommends Approval of Xadago™ (Safinamide) to Treat Parkinson´s Disease in EU sim00 Parkinson's Disease 3 12-29-2014 01:18 PM
OMG, I was just approved! bunz50 Social Security Disability 16 04-04-2011 07:11 AM
OMG, I was just approved! bunz50 Thoracic Outlet Syndrome 4 03-27-2011 03:11 PM
YEA!!! It's been approved lostmary Reflex Sympathetic Dystrophy (RSD and CRPS) 7 07-25-2008 09:59 PM


All times are GMT -5. The time now is 07:51 PM.

Powered by vBulletin • Copyright ©2000 - 2024, Jelsoft Enterprises Ltd.

vBulletin Optimisation provided by vB Optimise v2.7.1 (Lite) - vBulletin Mods & Addons Copyright © 2024 DragonByte Technologies Ltd.
 

NeuroTalk Forums

Helping support those with neurological and related conditions.

 

All posts copyright their original authors.

The material on this site is for informational purposes only,
and is not a substitute for medical advice, diagnosis or treatment
provided by a qualified health care provider.

Always consult your doctor before trying anything you read here.

Home