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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: temozolomide
Date Designated: 11/25/2015
Orphan Designation: Treatment glioblastoma multiforme in pediatric patients
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
AmpliPharm Pharmaceuticals, LLC
970 Peachtree Industrial Boulevard
Suite 100
Suwanee, Georgia 30024
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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