GEMCITABINE HYDROCHLORIDE (nda200795)- (1GM/26.3ML (38MG/ML),2GM/52.6ML (38MG/ML),200MG/5.26ML (38MG/ML))

Generic Name	GEMCITABINE HYDROCHLORIDE	Innovator	HOSPIRA INC
Dosage	1GM/26.3ML (38MG/ML),2GM/52.6ML (38MG/ML),200MG/5.26ML (38MG/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	Gemcitabine Injection 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
5	0	3

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

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of GEMCITABINE HYDROCHLORIDE