ALOXI (nda021372)- (EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML),EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML))

Generic Name	PALONOSETRON HYDROCHLORIDE	Innovator	HELSINN HLTHCARE
Dosage	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML),EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2024-Jul-30	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Aloxi is indicated for: 1) the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, and 2) the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
17	2	16

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 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	**	**	-	-	-
EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	16

Manufacturing Details of ALOXI