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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
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.

Marketing approved:

1 Generic Name: Betaine
Trade Name: Cystadane
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* :  

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.