Details for New Drug Application (NDA): 204677
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NDA 204677 describes NEURACEQ, which is a drug marketed by Life Molecular and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the NEURACEQ profile page.
The generic ingredient in NEURACEQ is florbetaben f-18. One supplier is listed for this compound. Additional details are available on the florbetaben f-18 profile page.
The generic ingredient in NEURACEQ is florbetaben f-18. One supplier is listed for this compound. Additional details are available on the florbetaben f-18 profile page.
Summary for 204677
| Tradename: | NEURACEQ |
| Applicant: | Life Molecular |
| Ingredient: | florbetaben f-18 |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204677
Generic Entry Date for 204677*:
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: 204677
| Mechanism of Action | Positron Emitting Activity |
Suppliers and Packaging for NDA: 204677
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEURACEQ | florbetaben f-18 | SOLUTION;INTRAVENOUS | 204677 | NDA | Life Molecular Imaging, Ltd | 54828-001 | 54828-001-50 | 1 VIAL, MULTI-DOSE in 1 CONTAINER (54828-001-50) / 50 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1.4-135mCi/ML | ||||
| Approval Date: | Mar 19, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 18, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | NEURACEQ IS A RADIOACTIVE DIAGNOSTIC AGENT FOR POSITRON EMISSION TOMOGRAPHY (PET) IMAGING OF THE BRAIN TO ESTIMATE P-AMYLOID NEURITIC PLAQUE DENSITY IN ADULT PATIENTS WITH COGNITIVE IMPAIRMENT | ||||||||
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