LESCOL (nda020261)- (EQ 20MG BASE,EQ 40MG BASE)

Generic Name	FLUVASTATIN SODIUM	Innovator	NOVARTIS
Dosage	EQ 20MG BASE,EQ 40MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2012-Jun-12	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LESCOL/ LESCOL XL is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: • Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia • Reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy • Reduce the risk of undergoing revascularization procedures in patients with clinically evident CHD • Slow the progression of atherosclerosis in patients with CHD

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

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 20MG BASE	**	**	-	-	2
EQ 40MG BASE	**	**	-	-	2

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	2

Manufacturing Details of LESCOL