SKYLA (nda203159)- (13.5MG)

Generic Name	LEVONORGESTREL	Innovator	BAYER HLTHCARE
Dosage	13.5MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2031-Apr-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2016-Jan-09
GAIN Expiry	None	Drug Complexity	No
Indication	Skyla is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to 3 years.

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
13.5MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of SKYLA