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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: fidaxomicin
Trade Name: Dificid
Date Designated: 12/13/2010
Orphan Designation: Treatment of pediatric Clostridium difficile infection
Orphan Designation Status: Designated/Approved
Cubist Pharmaceuticals LLC, a subsidiary of Merck Sharp & Dohme LLC
20 Weystrasse
Luzern, Luzern
Switzerland

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

Marketing approved:

1 Generic Name: fidaxomicin
Trade Name: Dificid
Marketing Approval Date: 01/24/2020
Approved Labeled Indication: DIFICID® is indicated in adult and pediatric patients aged 6 months and older for the treatment of C. difficile-associated diarrhea (CDAD).
Exclusivity End Date: 01/24/2027 
Exclusivity Protected Indication* :  Dificid (fidaxomicin) is indicated for pediatric patients aged 6 months and older for the treatment of C. difficile-associated diarrhea (CDAD).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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