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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
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.

Marketing approved:

1 Generic Name: pafolacianine
Trade Name: Cytalux
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: 11/29/2028 
Exclusivity Protected Indication* :  As an adjunct for intraoperative identification of malignant lesions in adult patients with ovarian cancer
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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