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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: trofinetide
Trade Name: Daybue
Date Designated: 02/11/2015
Orphan Designation: Treatment of Rett syndrome
Orphan Designation Status: Designated/Approved
Acadia Pharmaceuticals Inc.
3611 Valley Centre Drive
Suite 300
San Diego, California 92130
United States

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

Marketing approved:

1 Generic Name: trofinetide
Trade Name: Daybue
Marketing Approval Date: 03/10/2023
Approved Labeled Indication: treatment of Rett syndrome in adults and pediatric patients 2 years of age and older
Exclusivity End Date: 03/10/2030 
Exclusivity Protected Indication* :  treatment of Rett syndrome in adults and pediatric patients 2 years of age and older
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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