ALAWAY (nda021996)- (EQ 0.025% BASE)

Generic Name	KETOTIFEN FUMARATE	Innovator	BAUSCH AND LOMB
Dosage	EQ 0.025% BASE
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ALAWAY is indicated for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	0	5

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.025% BASE	**	**	Up	1	2

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of ALAWAY