Please visit our MS learning channel on Youtube, which provides hundreds of topics from our education programs, that were video-recorded and archived here: www.youtube.com/msviewsandnews -- Be empowered with MS news by registering with us: www.register.msviewsandnews.org

joomla ecommerce template -- Scroll left side of this blog for needed resources. Also, use our 'search by topic' tool, to find specific information.

Disclaimer: 'MS Views and News' DOES NOT endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.

============================================================

Friday, May 30, 2014

Genzyme’s Lemtrada Resubmission Accepted for Review by FDA

CAMBRIDGE, Mass., May 30, 2014 (BUSINESS WIRE) -- Genzyme, a Sanofi company , announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmission of its supplemental Biologics License Application (sBLA) seeking approval of LemtradaTM (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A six-month review period has been assigned for the Lemtrada sBLA. Genzyme expects FDA action on the sBLA in the fourth quarter.
This resubmission is based on data from the same clinical studies included in the original sBLA, and provides supplemental analyses and additional information to specifically address issues previously noted by the FDA in its December 27, 2013 Complete Response Letter. The company resubmitted the sBLA earlier this month following constructive discussions with the agency.



……..
To comment - click the comment link shown below
Share our Articles with others
……
MS Views and News / Stu's Views & MS News 
provide education, information and resources 
for those affected by Multiple Sclerosis

To Keep CURRENT  and up to date with MS News and Information
Sign-up at:  www.msviewsandnews.org 

WATCH OUR MS EDUCATIONAL VIDEOS by Topic, found here: www.youtube.com/msviewsandnews

JOIN our Facebook Page: www.facebook.com/msviewsandnews


 -------------

Thank you   

Stu's Views & MS News, is a publication of: 
…………………….


No comments: