Search Orphan Drug Designations and Approvals
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| Generic Name: | pafolacianine | |||||||||||||
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| 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 | |||||||||||||
| 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. |
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Marketing approved: |
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| 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: | TBD | |
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