FINTEPLA (nda212102)- (EQ 2.2MG BASE/ML)

Generic Name	FENFLURAMINE HYDROCHLORIDE	Innovator	UCB INC
Dosage	EQ 2.2MG BASE/ML
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2039-Oct-22	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2023-Jun-25
GAIN Expiry	None	Drug Complexity	No
Indication	FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	0

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 2.2MG BASE/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of FINTEPLA