FRANKFURT, Nov 26 (Reuters) – The U.S. drugs watchdog will take more time to decide over Merck KGaA’s (MRCG.DE) multiple sclerosis (MS) pill, the German company said on Friday, two months after drawing a rejection from European regulators.
The U.S. Food and Drug Administration (FDA) extended its review period for cladribine pills as a therapy for relapsing forms of (MS) by three months to Feb. 28, 2011, Merck said.
“The FDA extended the review period to provide additional time for a full review of additional information provided under the new drug application,” the company added.
***********************************************************
“Providing You with ‘MS Views and News’, is what we do“
Keep Informed and up–to–date with information concerning
Multiple Sclerosis when registered at
the MS Views and News website.
****************************************************************
Disclaimer: ‘MS Views and News’ (MSVN), 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.
. ****************************************************************
Visit our MS Learning Channel on YouTube: http://www.youtube.com/msviewsandnews