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AMYVID (nda202008)- (10ML (13.5-51mCi/ML),10-30ML (13.5-51mCi/ML),10-50ML (13.5-51mCi/ML),10-100ML (13.5-51mCi/ML))

FLORBETAPIR F-18 AVID RADIOPHARMS INC
10ML (13.5-51mCi/ML),10-30ML (13.5-51mCi/ML),10-50ML (13.5-51mCi/ML),10-100ML (13.5-51mCi/ML)
No No
2027-Apr-30 2017-Apr-06
None None
None No
Amyvid is a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Amyvid scan indicates sparse to no neuritic plaques, and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD.
0 0 0
Total Other Developers None
Drugs with Suitability No
10ML (13.5-51mCi/ML) ** ** - - -
10-30ML (13.5-51mCi/ML) ** ** - - -
10-50ML (13.5-51mCi/ML) ** ** - - -
10-100ML (13.5-51mCi/ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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