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Search results for nonoxynol root_Validation_@count in root_Validation_@count (approximate match)
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2012)
Source URL:
First approved in 2008
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
NCT03177538: Phase 4 Interventional Completed Infertility, Female
(2017)
Source URL:
First approved in 2005
Source:
PLUSET by Minitube of America, Inc.
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 1978
Source:
K-PhosNo. 2 by Beach Products, Inc.
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
NCT04370145: Phase 4 Interventional Completed Cholangitis, Secondary Biliary
(2021)
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(2016)
Source:
BLA761034
(2016)
Source URL:
First approved in 2016
Source:
BLA761034
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2013)
Source:
BLA125486
(2013)
Source URL:
First approved in 2013
Source:
BLA125486
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2011)
Source:
BLA125377
(2011)
Source URL:
First approved in 2011
Source:
BLA125377
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2010)
Source:
NDA022341
(2010)
Source URL:
First approved in 2010
Source:
NDA022341
Source URL:
Class:
PROTEIN
Conditions:
Liraglutide is an acylated human Glucagon-Like Peptide-1 (GLP-1) receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7-37). GLP-1(7-37) represents <20% of total circulating endogenous GLP-1. Like GLP-1(7-37), liraglutide activates the GLP-1 receptor, a membranebound cell-surface receptor coupled to adenylyl cyclase by the stimulatory G-protein, Gs, in pancreatic beta cells. Liraglutide increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations. This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia. Liraglutide also decreases glucagon secretion in a
glucose-dependent manner. The mechanism of blood glucose lowering also involves a delay in gastric emptying. GLP-1(7-37) has a half-life of 1.5-2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase IV (DPP-IV) and neutral endopeptidases (NEP). Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration. The pharmacokinetic profile of liraglutide, which makes it suitable for once daily administration, is a result of self-association that delays absorption, plasma protein binding and stability against metabolic degradation by DPP-IV and NEP. Liraglutide, a subcutaneous, once-daily GLP-1 agonist, is approved for the treatment of type 2 diabetes in the United States and Europe. It also has been studied for weight loss. Liraglutide helps to induce and sustain weight loss in patients with obesity. Its efficacy is comparable to other available agents but it offers the unique benefit of improved glycemic control.
Status:
US Approved Rx
(2016)
Source:
BLA208673
(2016)
Source URL:
First approved in 2000
Source:
BLA021081
Source URL:
Class:
PROTEIN
Targets:
Insulin glargine, a long-acting form of insulin, was marketed under the brand name LANTUS. Lantus is indicated for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. The primary activity of insulin glargine is regulation of glucose metabolism. It lowers blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. The off-label use of insulin glargine is the treatment type 2 diabetes in children and the treatment of gestational diabetes.
Status:
US Approved Rx
(1989)
Source:
BLA103234
(1989)
Source URL:
First approved in 1989
Source:
BLA103234
Source URL:
Class:
PROTEIN