NOLVADEX (nda017970)- (EQ 10MG BASE,EQ 20MG BASE)

Generic Name	TAMOXIFEN CITRATE	Innovator	ASTRAZENECA
Dosage	EQ 10MG BASE,EQ 20MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2003-Feb-20	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	OLVADEX is effective in the treatment of metastatic breast cancer in women and men. NOLVADEX is indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. NOLVADEX is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. NOLVADEX reduces the occurrence of contralateral breast cancer in patients receiving adjuvant NOLVADEX therapy for breast cancer.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	5

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 10MG BASE	**	**	-	-	4
EQ 20MG BASE	**	**	-	-	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	5

Manufacturing Details of NOLVADEX