PHOTOFRIN (nda020451)- (75MG/VIAL)

Generic Name	PORFIMER SODIUM	Innovator	PINNACLE BIOLGS
Dosage	75MG/VIAL
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2012-Aug-01	NCE Excl Expiry	Expired
ODE Expiry	2010-Aug-01	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PHOTOFRIN is a photoactivated radical generator indicated for: Esophageal Cancer  Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy Endobronchial Cancer  Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated  Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett’s Esophagus  Ablation of high-grade dysplasia (HGD) in Barrett’s esophagus (BE) patients who do not undergo esophagectomy

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
75MG/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of PHOTOFRIN