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Search results for m root_Display\ Name in Display Name (approximate match)
Status:
Other
Class:
POLYMER
Status:
Other
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
M020
(2020)
Source URL:
First approved in 2009
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2004)
Source URL:
First approved in 2004
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2001)
Source URL:
First approved in 2001
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Other
Class:
STRUCTURALLY DIVERSE
Status:
Possibly Marketed Outside US
Source:
BLA103189
(2009)
Source URL:
First approved in 2009
Source:
BLA103189
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Other
Class:
G1 SPECIFIED SUBSTANCE
Status:
US Approved Rx
(2016)
Source:
NDA206679
(2016)
Source URL:
First approved in 1991
Source:
NDA019766
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Simvastatin is a HMG-CoA Reductase Inhibitor that is FDA approved for the treatment of hypercholesterolemia and for the reduction in the risk of cardiac heart disease mortality and cardiovascular events. It reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL). Common adverse reactions include abdominal pain, constipation, nausea, headache, upper respiratory infection. Cases of myopathy/rhabdomyolysis have been observed with simvastatin co-administered with lipid-modifying doses ( ≥ 1 g/day niacin) of niacin-containing products. The risk of myopathy, including rhabdomyolysis, is increased by concomitant administration of amiodarone, dronedarone, ranolazine, or calcium channel blockers such as verapamil, diltiazem, or amlodipine.