AXID (nda019508)- (150MG,300MG)

Generic Name	NIZATIDINE	Innovator	SMITHKLINE BEECHAM
Dosage	150MG,300MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2002-Apr-12	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Axid is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Axid is indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with Axid for longer than 1 year are not known. Axid is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD. Axid is indicated for up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	3

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
150MG	**	**	-	-	1
300MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of AXID