KYTRIL (nda020239)- (EQ 3MG BASE/ML,EQ 4MG BASE/4ML (EQ 1MG BASE/ML),EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML),EQ 1MG BASE/ML (EQ 1MG BASE/ML))

Generic Name	GRANISETRON HYDROCHLORIDE	Innovator	ROCHE
Dosage	EQ 3MG BASE/ML,EQ 4MG BASE/4ML (EQ 1MG BASE/ML),EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML),EQ 1MG BASE/ML (EQ 1MG BASE/ML)
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2019-May-04	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	KYTRIL Injection is a serotonin-3 (5-HT3) receptor antagonist indicated for: • Prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. • Prevention and treatment of postoperative nausea and vomiting in adults.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
26	0	4

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
EQ 3MG BASE/ML	**	**	-	-	-
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	**	**	-	-	-
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)	**	**	-	-	-
EQ 1MG BASE/ML (EQ 1MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	3

Manufacturing Details of KYTRIL