GANITE (nda019961)- (25MG/ML)

Generic Name	GALLIUM NITRATE	Innovator	CHAPTER 7 TRUSTEE
Dosage	25MG/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2005-Jan-17	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Ganite is indicated for the treatment of clearly symptomatic cancer-related hypercalcemia that has not responded to adequate hydration. In general, patients with a serum calcium (corrected for albumin) < 12 mg/dL would not be expected to be symptomatic. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without diuretics). In the treatment of cancer-related hypercalcemia, it is important first to establish adequate hydration, preferably with intravenous saline, in order to increase the renal excretion of calcium and correct dehydration caused by hypercalcemia.

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
25MG/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of GANITE