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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  pafolacianine
Trade Name:  Cytalux
Date Designated:  12/23/2014
Orphan Designation:  Detecting folic receptor alpha positive lesions in ovarian cancer patients (diagnostic for the management of ovarian cancer)
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  11/29/2021 
Approved Labeled Indication:  As an adjunct for intraoperative identification of malignant lesions in adult patients with ovarian cancer
Exclusivity End Date:     
Exclusivity Protected Indication* :  
On Target Laboratories, LLC
1282 Win Hentschel Blvd
West Lafayette, Indiana 47906
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.