Details for New Drug Application (NDA): 214907
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NDA 214907 describes CYTALUX, which is a drug marketed by On Target Labs and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the CYTALUX profile page.
The generic ingredient in CYTALUX is pafolacianine sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pafolacianine sodium profile page.
The generic ingredient in CYTALUX is pafolacianine sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pafolacianine sodium profile page.
Summary for 214907
| Tradename: | CYTALUX |
| Applicant: | On Target Labs |
| Ingredient: | pafolacianine sodium |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214907
Generic Entry Date for 214907*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 214907
| Mechanism of Action | Fluorescence Contrast Activity |
Suppliers and Packaging for NDA: 214907
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYTALUX | pafolacianine sodium | SOLUTION;INTRAVENOUS | 214907 | NDA | On Target Laboratories, Inc. | 81052-138 | 81052-138-10 | 10 CARTON in 1 CARTON (81052-138-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1.6 mL in 1 VIAL, SINGLE-DOSE (81052-138-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) | ||||
| Approval Date: | Nov 29, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 29, 2028 | ||||||||
| Regulatory Exclusivity Use: | AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS IN ADULT PATIENTS WITH OVARIAN CANCER | ||||||||
| Regulatory Exclusivity Expiration: | Nov 29, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,881,747 | Patent Expiration: | Aug 26, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS | ||||||||
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