Search Orphan Drug Designations and Approvals
-
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* : | |
Sponsor: |
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. |
-