PREXXARTAN (nda209139)- (4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)

Generic Name	VALSARTAN	Innovator	CARMEL BIOSCIENCES
Dosage	4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PREXXARTAN is an angiotensin II receptor blocker (ARB) indicated for:  Hypertension in adults and children six years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions  Heart failure (NYHA class II-IV); PREXXARTAN significantly reduces hospitalization for heart failure in patients who are unable to swallow valsartan tablets  Stable left ventricular failure or left ventricular dysfunction following myocardial infarction; PREXXARTAN reduces cardiovascular mortality in patients who are unable to swallow valsartan tablets.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

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
4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of PREXXARTAN