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))

Generic Name	FLORBETAPIR F-18	Innovator	AVID RADIOPHARMS INC
Dosage	10ML (13.5-51mCi/ML),10-30ML (13.5-51mCi/ML),10-50ML (13.5-51mCi/ML),10-100ML (13.5-51mCi/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2027-Apr-30	NCE Excl Expiry	2017-Apr-06
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	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.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
10ML (13.5-51mCi/ML)	**	**	-	-	-
10-30ML (13.5-51mCi/ML)	**	**	-	-	-
10-50ML (13.5-51mCi/ML)	**	**	-	-	-
10-100ML (13.5-51mCi/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of AMYVID