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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: posaconazole
Trade Name: Noxafil
Date Designated: 10/04/2016
Orphan Designation: Treatment of invasive aspergillosis
Orphan Designation Status: Designated/Approved
Merck Sharp & Dohme LLC
126 East Lincoln Ave.
P.O. Box 2000
Rahway, New Jersey 07065
United States

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

Marketing approved:

1 Generic Name: posaconazole
Trade Name: Noxafil
Marketing Approval Date: 06/17/2021
Approved Labeled Indication: Treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older
Exclusivity End Date: 06/17/2028 
Exclusivity Protected Indication* :  Treatment of invasive aspergillosis in adults and pediatric patients 13 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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