Genzyme to Resubmit Lemtrada Application for FDA Review - - BioPharm International

ADVERTISEMENT

Genzyme to Resubmit Lemtrada Application for FDA Review



Sanofi and its subsidiary Genzyme reported that the company plans to resubmit its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. The resubmission will provide information to specifically address issues noted by the FDA in its Dec. 27, 2013 Complete Response Letter.

Genzyme had previously announced its intention to appeal the FDA's Complete Response Letter. As a result of the planned resubmission, the company does not expect to pursue an appeal at this time.

Source: Sanofi

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
Author Guidelines

Click here