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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tadalafil
Trade Name: Adcirca
Date Designated: 12/18/2006
Orphan Designation: Treatment of pulmonary arterial hypertension
Orphan Designation Status: Designated/Approved
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
United States

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

Marketing approved:

1 Generic Name: tadalafil
Trade Name: Adcirca
Marketing Approval Date: 05/22/2009
Approved Labeled Indication: Treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability
Exclusivity End Date: 05/22/2016 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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