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FDA Approval for Generic Rosuvastatin

Health In Focus   - G J E 4
  • 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.
FDA Approval for Generic Rosuvastatin
FDA Approval for Generic Rosuvastatin
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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.

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

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.

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