SYMLIN (nda021332)- (EQ 3MG BASE/5ML (EQ 600MCG BASE/ML),EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML),EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML))

Generic Name	PRAMLINTIDE ACETATE	Innovator	ASTRAZENECA AB
Dosage	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML),EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML),EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2019-Mar-16	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SYMLIN is an amylin analog indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	**	**	-	-	-
EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	**	**	-	-	-
EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of SYMLIN