VALIUM (nda013263)- (2MG,5MG,10MG)

Generic Name	DIAZEPAM	Innovator	WAYLIS THERAP
Dosage	2MG,5MG,10MG
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	Valium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis Valium is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral Valium may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
10	0	9

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
2MG	**	**	-	-	3
5MG	**	**	-	-	3
10MG	**	**	-	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	8

Manufacturing Details of VALIUM