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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: tenofovir
Trade Name: Viread
Date Designated: 03/17/2009
Orphan Designation: Treatment of pediatric HIV infection.
Orphan Designation Status: Designated/Approved
Gilead Sciences, Inc.
333 Lakeside Drive
Foster city, California 94404
United States

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

Marketing approved:

1 Generic Name: tenofovir
Trade Name: Viread
Marketing Approval Date: 03/24/2010
Approved Labeled Indication: Treatment of HIV infection in combination with other antiretroviral agents in patients 12 to less than 18 years of age
Exclusivity End Date: 03/24/2017 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.