SOOLANTRA (nda206255)- (1%)

Generic Name	IVERMECTIN	Innovator	GALDERMA LABS LP
Dosage	1%
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2034-Mar-13	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2017-Dec-19
GAIN Expiry	None	Drug Complexity	No
Indication	SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

Other Developers

Total Other Developers	13

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1%	**	**	-	-	2

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of SOOLANTRA