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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Betulinic acid
Date Designated: 08/09/2007
Orphan Designation: Topical treatment of metastatic melanoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Advanced Life Sciences, Inc. (ALS)
1440 Davey Road
Woodridge, Illinois 60517
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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