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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Betaine
Trade Name:  Cystadane
Date Designated:  05/16/1994
Orphan Designation:  Treatment of homocystinuria.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  10/25/1996 
Approved Labeled Indication:  Treatment of homocystinuria to decrease elevated homocysteine blood levels.
Exclusivity End Date:   10/25/2003
Orphan Europe SARL
70 Avenue du Général de Gaulle

The sponsor address listed is the last reported by the sponsor to OOPD.