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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: ondansetron inhalation powder
Date Designated: 10/14/2015
Orphan Designation: Prevention of chemotherapy-induced nausea and vomiting due to highly emetogenic chemotherapy in pediatric patients (0 through 16 years of age) .
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Luxena Pharmaceuticals, Inc.
1400 Coleman Avenue
Suite D27
Santa Clara, California 95050
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.