FDA Approves the First Generic Version of Crestor

On April 29th, 2016 the U.S. Food and Drug Administration released the approval for the first generic version of Crestor tablets.  These tablets are called Rosuvastatin Calcium and are used mainly for treating adults with hypertriglyceridemia, which are high triglycerides in the body.  These tablets will also help to treat patients with hypolipoproteinemia and familial hypercholesterolemia, which are disorders associated with the improper breakdown of general and high low-density lipoprotein (LDL) cholesterol.  Having high LDL cholesterol limits and high triglycerides content within your body is a risk factor for heart disease, heart attack and stroke.  The first company to gain approval to market generic Rosuvastin Calcium was Watson Pharmaceuticals Inc located in Parsippany, New Jersey.

The FDA is an agency within the U.S. Department of Health and Human Services which protects the public health by ensuring that drugs, vaccines and other biological products for human use all follow the same safety, effectiveness and security standards.  The FDA is actively working to get these generic drugs approved as quickly as possible so that patients with these disorders can have an increased access to needed treatment.  It is important to understand that generic drugs must meet the same rigorous scientific and quality standards as do the brand-name drugs, meaning they have the same quality and strength.

This product is in a class of drugs known as statins, which stop the HMG-CoA enzyme within the patient’s body from producing cholesterol.  This makes sure that the patient does not have high cholesterol and thus, an increased risk of heart disease.  It is important for consumers to understand the risk associated with these drugs and should only be taken under the prescription of a doctor.

As a team of qualified Drug Regulatory Consultants for over 20 years, you can trust Focal Point Research to give you updated information, along with help to bring your drugs through regulatory approval in North America.