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Details for New Drug Application (NDA): 202008

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NDA 202008 describes AMYVID, which is a drug marketed by Avid Radiopharms Inc 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 AMYVID profile page.

The generic ingredient in AMYVID is florbetapir f-18. One supplier is listed for this compound. Additional details are available on the florbetapir f-18 profile page.

Summary for NDA: 202008

Tradename:
AMYVID
Applicant:
Avid Radiopharms Inc
Ingredient:
florbetapir f-18
Patents:2

Pharmacology for NDA: 202008

Mechanism of ActionPositron Emitting Activity

Suppliers and Packaging for NDA: 202008

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMYVID
florbetapir f-18
SOLUTION;INTRAVENOUS 202008 NDA Eli Lilly and Company 0002-1200 0002-1200-30 1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-30) > 30 mL in 1 VIAL, MULTI-DOSE
AMYVID
florbetapir f-18
SOLUTION;INTRAVENOUS 202008 NDA Eli Lilly and Company 0002-1200 0002-1200-50 1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-50) > 50 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength10ML (13.5-51mCi/ML)
Approval Date:Apr 6, 2012TE:RLD:No
Patent:7,687,052Patent Expiration:Apr 30, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:8,506,929Patent Expiration:Apr 30, 2027Product Flag?YSubstance Flag?YDelist Request?
Patented Use:AMYVID IS A RADIOACTIVE DIAGNOSTIC AGENT FOR POSITRON EMISSION TOMOGRAPHY (PET) IMAGING OF THE BRAIN TO ESTIMATE BETA-AMYLOID NEURITIC PLAQUE DENSITY IN ADULT PATIENTS WITH COGNITIVE IMPAIRMENT
Regulatory Exclusivity Expiration:Apr 6, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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