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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: lenzumestrocel
Date Designated: 08/01/2018
Orphan Designation: Treatment of amyotrophic lateral sclerosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Corestem, Inc.
2F, 24, Pangyo-ro 255 beon-gil
Bundang-gu
Seongnam-si, Gyeonggi-do
South Korea

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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