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Saturday, March 14, 2009

“COPAXONE® Approved by the FDA for Patients with a First Clinical Event Suggestive of Multiple Sclerosis”

Re-printed today March 14, 2009 at the request of others who missed this posting when it first printed to this blog:


Information found here provided by: MS Views and News, Inc

Business Wire

March 3, 2009

JERUSALEM - (BUSINESS WIRE) - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for COPAXONE(®) (glatiramer acetate injection) to include the treatment of patients who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with multiple sclerosis (MS).


The FDA’s approval follows a similar decision by the Medicines and Healthcare Products Regulatory Agency (MHRA) in February 2009 under which 24 EU member states have mutually recognized an expanded label for COPAXONE(® )to include the treatment of patients with clinically isolated syndrome (CIS) suggestive of MS.

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