TOPOTECAN (nda200199)- (EQ 1MG BASE/ML (EQ 1MG BASE/ML),EQ 3MG BASE/3ML (EQ 1MG BASE/ML),EQ 4MG BASE/4ML (EQ 1MG BASE/ML))

Generic Name	TOPOTECAN HYDROCHLORIDE	Innovator	SANDOZ INC
Dosage	EQ 1MG BASE/ML (EQ 1MG BASE/ML),EQ 3MG BASE/3ML (EQ 1MG BASE/ML),EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
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	Topotecan is a topoisomerase inhibitor indicated for:  small cell lung cancer sensitive disease after failure of first-line chemotherapy.  combination therapy with cisplatin for stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1MG BASE/ML (EQ 1MG BASE/ML)	**	**	-	-	-
EQ 3MG BASE/3ML (EQ 1MG BASE/ML)	**	**	-	-	-
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of TOPOTECAN