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Search results for "Established Pharmacologic Class [EPC]" in comments (approximate match)
Status:
US Approved Rx
(2006)
Source:
BLA125151
(2006)
Source URL:
First approved in 2006
Source:
BLA125151
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2005)
Source:
NDA021773
(2005)
Source URL:
First approved in 2005
Source:
NDA021773
Source URL:
Class:
PROTEIN
Conditions:
Exenatide (exendin-4) is sold under the brand name BYETTA to improve glycemic control in people with type 2 diabetes mellitus. Exenatide is a glucagon-like peptide 1 (GLP-1) receptor agonist that enhances glucose-dependent insulin secretion by the pancreatic beta cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying. The drug also moderates peak serum glucagon levels during hyperglycemic periods following meals but does not interfere with glucagon release in response to hypoglycemia.
Status:
US Approved Rx
(2024)
Source:
BLA761381
(2024)
Source URL:
First approved in 2005
Source:
BLA021859
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2005)
Source:
BLA125117
(2005)
Source URL:
First approved in 2005
Source:
BLA125117
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2005)
Source:
NDA021332
(2005)
Source URL:
First approved in 2005
Source:
NDA021332
Source URL:
Class:
PROTEIN
Conditions:
Pramlintide is an analog of human amylin. Amylin is co-secreted with insulin from pancreatic beta cells and acts centrally to slow gastric emptying, suppress postprandial glucagon secretion, and decrease food intake. These actions complement those of insulin to regulate blood glucose concentrations. Amylin is relatively deficient in patients with type 2 diabetes, depending on the severity of beta-cell secretory failure, and is essentially absent in patients with type 1 diabetes. Through mechanisms similar to those of amylin, pramlintide improves overall glycemic control, reduces postprandial glucose levels, and reduces bodyweight in patients with diabetes using mealtime insulin. SYMLIN® (pramlintide acetate) is 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.
Status:
US Approved Rx
(2005)
Source:
BLA021536
(2005)
Source URL:
First approved in 2005
Source:
BLA021536
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Insulin detemir, a long-acting human insulin analog, is sold under the brand name LEVEMIR to improve glycemic control in adults and children with diabetes mellitus. Insulin detemir binds to the insulin receptor. Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver. The primary activity of insulin detemir is the regulation of glucose metabolism. Insulin detemir crosses the BBB and reduces food intake, it improves weight management by an enhanced and prolonged centrally mediated reduction of energy intake.
Status:
US Approved Rx
(2005)
Source:
BLA125118
(2005)
Source URL:
First approved in 2005
Source:
BLA125118
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2022)
Source:
BLA761268
(2022)
Source URL:
First approved in 2004
Source:
BLA125085
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2004)
Source:
BLA021629
(2004)
Source URL:
First approved in 2004
Source:
BLA021629
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2004)
Source:
BLA125104
(2004)
Source URL:
First approved in 2004
Source:
BLA125104
Source URL:
Class:
PROTEIN