SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS (nda021084)- (50%;50%)

Generic Name	PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE	Innovator	US ARMY MED RES
Dosage	50%;50%
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2015-May-30	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SERPACWA is indicated only in conjunction with MOPP gear to reduce or delay the absorption of chemical warfare agents through the skin when SERPACWA is applied prior to exposure.

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
50%;50%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS