INTRAROSA (nda208470)- (6.5MG)

Generic Name	PRASTERONE	Innovator	MILLICENT
Dosage	6.5MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2031-Mar-19	NCE Excl Expiry	2021-Nov-16
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	INTRAROSA™ is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

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
6.5MG	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of INTRAROSA