PRELAY (nda020719)- (200MG,300MG,400MG)

Generic Name	TROGLITAZONE	Innovator	SANKYO
Dosage	200MG,300MG,400MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2017-Nov-13	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Prelay is indicated to improve glycemic control in patients with type 2 diabetes mellitus as an adjunct to diet and exercise in combination with (not substituted for): * A sulfonylurea drug for patients who are not adequately controlled with a sulfonylurea alone, or * A sulfonylurea drug together with metformin for patients who are not adequately controlled with the combination of a sulfonylurea and metformin, or * Insulin in patients who are not adequately controlled with insulin alone. Prelay is not indicated as initial therapy in patients with type 2 diabetes.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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
200MG	**	**	-	-	-
300MG	**	**	-	-	-
400MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of PRELAY