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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: Rapamune
Date Designated: 10/31/2012
Orphan Designation: Treatment of lymphangioleiomyomatosis
Orphan Designation Status: Designated/Approved
Pfizer, Inc.
500 Arcola Road
Collegeville, Pennsylvania 19426
United States

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

Marketing approved:

1 Generic Name: sirolimus
Trade Name: Rapamune
Marketing Approval Date: 05/28/2015
Approved Labeled Indication: Treatment of lymphangioleiomyomatosis (LAM)
Exclusivity End Date: 05/28/2022 
Exclusivity Protected Indication* :  Treatment of lymphangioleiomyomatosis (LAM)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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