HYCAMTIN (nda020671)- (EQ 4MG BASE/VIAL)

Generic Name	TOPOTECAN HYDROCHLORIDE	Innovator	SANDOZ
Dosage	EQ 4MG BASE/VIAL
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2015-Apr-07	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	0	4

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 4MG BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of HYCAMTIN