Details for New Drug Application (NDA): 216023
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NDA 216023 describes POSLUMA, which is a drug marketed by Blue Earth and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the POSLUMA profile page.
The generic ingredient in POSLUMA is flotufolastat f-18 gallium. One supplier is listed for this compound. Additional details are available on the flotufolastat f-18 gallium profile page.
The generic ingredient in POSLUMA is flotufolastat f-18 gallium. One supplier is listed for this compound. Additional details are available on the flotufolastat f-18 gallium profile page.
Summary for 216023
| Tradename: | POSLUMA |
| Applicant: | Blue Earth |
| Ingredient: | flotufolastat f-18 gallium |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216023
Generic Entry Date for 216023*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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: 216023
| Mechanism of Action | Positron Emitting Activity |
Suppliers and Packaging for NDA: 216023
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POSLUMA | flotufolastat f-18 gallium | SOLUTION;INTRAVENOUS | 216023 | NDA | Blue Earth Diagnostics | 69932-002 | 69932-002-50 | 25 mL in 1 VIAL, MULTI-DOSE (69932-002-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 25ML (8-158mCi/ML) | ||||
| Approval Date: | May 25, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 25, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 22, 2038 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | POSITRON EMISSION TOMOGRAPHY (PET) OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA) POSITIVE LESIONS IN MEN WITH PROSTATE CANCER WITH SUSPECTED METASTASIS WHO ARE CANDIDATES FOR INITIAL DEFINITIVE THERAPY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 22, 2038 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | POSITRON EMISSION TOMOGRAPHY (PET) OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA) POSITIVE LESIONS IN MEN WITH PROSTATE CANCER WITH SUSPECTED RECURRENCE BASED ON ELEVATED SERUM PROSTATE-SPECIFIC ANTIGEN (PSA) LEVEL | ||||||||
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