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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sirolimus
Trade Name: Hyftor
Date Designated: 05/17/2017
Orphan Designation: Treatment of angiofibroma associated with tuberous sclerosis
Orphan Designation Status: Designated/Approved
NobelPharma Co., LTD
12-10 Nihonbashi-kobunacho
Chuo-ku, Tokyo-to
Japan

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

Marketing approved:

1 Generic Name: sirolimus
Trade Name: Hyftor
Marketing Approval Date: 03/22/2022
Approved Labeled Indication: treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older
Exclusivity End Date: 03/22/2029 
Exclusivity Protected Indication* :  treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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