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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: valsartan oral solution
Date Designated: 10/28/2015
Orphan Designation: Treatment of hypertension in pediatric patients 0 through 16 years of age
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 04/28/2016
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Carmel Biosciences
5673 Peachtree Dunwoody Road
Suite 440
Atlanta, Georgia 30342
United States

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

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.