FDA Approval for Generic Rosuvastatin

FDA approves a generic form of rosuvastatin which is potent in controlling lipid levels in the blood and is cost effective.

FDA approves generic rosuvastatin.
Rosuvastatin lowers lipid levels in the blood.
It can be used in the treatment for hypertriglyceridimia, type III hyperlipoproteinemia and homozygous familial hypercholesterolemia.

The Food and Drug Administration (FDA) has approved the use of generic rosuvastatin in the treatment of:

Hypertriglyceridimia in adults along with diet control
Type III Hyperlipoproteinemia along with diet control
Homozygous Familial Hypercholesterolemia in adults, alone or along with other cholesterol treatments

Approval of a generic form ensures that the same drug is available at a much lower cost, and is therefore more accessible to several individuals who cannot afford costly brands. The FDA ensures that the quality and standards of the generic drug is maintained through the same rigorous testing as that of the brand name drugs.

Mode of Action of Rosuvastatin

Rosuvastatin belongs to a group of drugs called statins. Rosuvastatin and other statins inhibit the enzyme HMG CoA reductase that is responsible for the formation of cholesterol.

The generic form of rosuvastatin called Crestor from Watson Pharmaceuticals is now approved by the U.S. Food and Drug Administration to lower the lipid levels.

Cholesterol Risk Calculator
The Cholesterol risk calculator assesses your risk for heart disease using the result of cholesterol test (lipid profile test).

‘Rosuvastatin, ‘the first generic cholesterol drug’ will now make treatment of high cholesterol more accessible at a lower cost.’

The drug should be consumed along with a strict diet that is low in cholesterol and saturated fats which will improve its effectiveness.

The Ability of Rosuvastatin to Lower Lipid Levels

Scientists Adams SP and colleagues carried out a study titled “Lipid-lowering Efficacy of Rosuvastatin” which was published in the Cochrane Database of Systematic Reviews 2014. This study aimed to understand the efficacy of the drug rosuvastatin on blood lipids.

High Cholesterol | Hypercholesterolemia - Causes, Symptoms, Diagnosis & Treatment
High cholesterol level in blood are a risk for heart disease and stroke. They get deposited in the wall of the arteries and clog the circulation posing a threat to life.

The effect of varying doses of rosuvastatin were studied on the level of:

High Density Lipoprotein (HDL)
Low Density Lipoprotein (LDL)
Serum total cholesterol
Non- HDL cholesterol
Triglycerides

The study reviewed 108 study trials that involved 19, 596 participants. The results of the study showed strong evidence towards the effectiveness of rosuvastatin in controlling lipid levels in the blood.

Results of the Study- Benefits of Rosuvastatin

LDL-cholesterol decreased by 46% to 55% with an intake of 10-40 mg of rosuvastatin per day.
There was dose dependent effect of rosuvastatin on the levels of

Serum cholesterol
LDL-cholesterol
Non- HDL cholesterol

Rosuvastatin was found to be three times more effective than atorvastatin in lowering LDL-cholesterol.
HDL-cholesterol was increased by 7% with the use of rosuvastatin, but this was not dose dependant.

Side Effects Associated with the Use of Rosuvastatin Include:

Headache
Muscle pain
Weakness
Nausea
Abdominal pain

Rosuvastatin should not be given to pregnant or lactating mothers to avoid any damage that it may cause to the fetus.

Hypertriglyceridemia - Causes Risk Factors Symptoms Signs Diagnosis Treatment
Triglycerides are a form of the fat, the major energy source found in our blood. High triglyceride levels/ hypertriglyceridemia are associated with conditions like pancreatitis.

High lipid levels in the blood cause a lot of health concerns and are associated with cardiovascular disease, diabetes and chronic kidney failure. It is triggered largely by poor lifestyle habits that include eating from fast food joints, sedentary lifestyle and lack of exercise. The accessibility to generic drugs that control the level of lipids in the blood, when taken along with a low fat diet, will aid in improving the health of the individual. The lowered costs will be a boon in making treatment affordable to patients.

References:

FDA approves first generic Crestor
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm498373.htm
Lipid-lowering efficacy of rosuvastatin.
https://www.ncbi.nlm.nih.gov/pubmed/25415541

Source-Medindia

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