ANCOBON (nda017001)- (250MG,500MG)

Generic Name	FLUCYTOSINE	Innovator	BAUSCH
Dosage	250MG,500MG
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	ANCOBON is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus. *Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine. *Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported. ANCOBON should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to ANCOBON

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	0	5

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
250MG	**	**	-	-	-
500MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	4

Manufacturing Details of ANCOBON