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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Recombinant adeno-associated virus serotype 9 vector expressing codon-optimized miniaturized version of DMD gene
Date Designated: 05/22/2017
Orphan Designation: Treatment of Duchenne Muscular Dystrophy (DMD)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bamboo Therapeutics, w wholly owned subsidiary of Pfizer
Worldwide Safety & Regulatory
Pfizer Inc.
Groton, Connecticut 06340
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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