BLENOXANE (nda050443)- (EQ 15 UNITS BASE/VIAL,EQ 30 UNITS BASE/VIAL)

Generic Name	BLEOMYCIN SULFATE	Innovator	BRISTOL MYERS SQUIBB
Dosage	EQ 15 UNITS BASE/VIAL,EQ 30 UNITS BASE/VIAL
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	BLENOXANE should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: * Squamous Cell Carcinoma - Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to BLENOXANE is poorer in patients with previously irradiated head and neck cancer. * Lymphomas - Hodgkin’s disease, non-Hodgkin’s lymphoma. * Testicular Carcinoma - Embryonal cell, choriocarcinoma, and teratocarcinoma. * BLENOXANE has also been shown to be useful in the management of: * Malignant Pleural Effusion - BLENOXANE is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	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 15 UNITS BASE/VIAL	**	**	-	-	4
EQ 30 UNITS BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	5

Manufacturing Details of BLENOXANE