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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 
Exclusivity Protected Indication* :  
Orphan Europe SARL
70 Avenue du Général de Gaulle
Puteaux, Île-de-France

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.