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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: 7-ethyl-10-hydroxycamptothecin (EHC)
Date Designated: 04/13/2016
Orphan Designation: Treatment of small cell lung cancer.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 02/21/2023
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Nippon Kayaku Co., Ltd.
1-1, Marunouchi 2-chome
Chiyoda, Tokyo

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.