ZOVIRAX (nda018603)- (EQ 500MG BASE/VIAL,EQ 1GM BASE/VIAL,EQ 250MG BASE/VIAL)

Generic Name	ACYCLOVIR SODIUM	Innovator	GLAXOSMITHKLINE
Dosage	EQ 500MG BASE/VIAL,EQ 1GM BASE/VIAL,EQ 250MG BASE/VIAL
ParaIV Filing	Yes	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	ZOVIRAX for Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients. ZOVIRAX for Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immunocompetent patients. ZOVIRAX for Injection is indicated for the treatment of herpes simplex encephalitis. ZOVIRAX for Injection is indicated for the treatment of neonates and infants with herpes simplex infections. ZOVIRAX for Injection is indicated for the treatment of varicella-zoster (shingles) infections in immunocompromised patients.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	4

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 500MG BASE/VIAL	**	**	-	-	-
EQ 1GM BASE/VIAL	**	**	-	-	-
EQ 250MG BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	3

Manufacturing Details of ZOVIRAX