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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: cenegermin-bkbj
Trade Name: Oxervate
Date Designated: 06/23/2014
Orphan Designation: Treatment of neurotrophic keratitis
Orphan Designation Status: Designated/Approved
Dompe S.p.A.
Via S. Martino 12-12/A
Milan
Italy

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: cenegermin-bkbj
Trade Name: Oxervate
Marketing Approval Date: 08/22/2018
Approved Labeled Indication: Treatment of neurotrophic keratitis
Exclusivity End Date: 08/22/2025 
Exclusivity Protected Indication* :  Treatment of neurotrophic keratitis
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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