AVGEMSI (NDA219920)- (EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML),EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML),EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML))

Generic Name	GEMCITABINE HYDROCHLORIDE	Innovator	AVYXA HOLDINGS
Dosage	EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML),EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML),EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	AVGEMSI is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. in combination with cisplatin, for the treatment of non-small cell lung cancer. as a single agent for the treatment of pancreatic cancer.

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
EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML)	**	**	-	-	-
EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML)	**	**	-	-	-
EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of AVGEMSI