VIOXX (nda021042)- (12.5MG,25MG,50MG)

Generic Name	ROFECOXIB	Innovator	MERCK
Dosage	12.5MG,25MG,50MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2017-Nov-25	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	VIOXX is indicated:  For relief of the signs and symptoms of osteoarthritis.  For relief of the signs and symptoms of rheumatoid arthritis in adults.  For relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older and who weigh 10 kg (22 lbs) or more.  For the management of acute pain in adults.  For the treatment of primary dysmenorrhea.  For the acute treatment of migraine attacks with or without aura in adults.

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
12.5MG	**	**	-	-	-
25MG	**	**	-	-	-
50MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of VIOXX