HHS NEWS

U.S. Department of Health and Human Services


STATEMENT                Print Media:        301-827-6242
FOR IMMEDIATE RELEASE    
May 12, l998             Consumer Inquiries: 800-532-4440
                        

FDA ISSUES APPROVABLE LETTER FOR ALS DRUG MYOTROPHIN

FDA today issued an "approvable" letter to the sponsors of Myotrophin -- a potential treatment for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease. The letter does not constitute an approval of the drug, but does provide details on what additional steps the manufacturer needs to take in order to gain approval.

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