TOPOTECAN HYDROCHLORIDE (nda022453)- (EQ 4MG BASE/4ML (EQ 1MG BASE/ML))

Generic Name	TOPOTECAN HYDROCHLORIDE	Innovator	MEITHEAL
Dosage	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 Injection is a topoisomerase inhibitor indicated for treatment of: • Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent • Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent • Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin

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
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TOPOTECAN HYDROCHLORIDE