The Food and Drug Administration (FDA) announced today that it is allowing the generic drug Crestor (rosuvastatin calcium) to be sold without a prescription. Crestor is the only statin approved to treat high cholesterol and is also approved by the FDA to prevent the development of a heart attack, as well as to lower LDL-cholesterol levels.
“The FDA is proud to announce that we have been granted access to the generic version of this important medication,” stated Janet Woodcock, FDA’s Acting Director of National Health Program.
The generic version of rosuvastatin is a brand-name product that is manufactured by AstraZeneca. Crestor is the only statin approved to treat high cholesterol and is also approved to prevent the development of a heart attack, as well as to lower LDL-cholesterol levels. In the absence of a prescription drug, access to a statin drug is limited and it is important to ensure patients do not have to obtain a prescription.
As a result, generic rosuvastatin is available at a cost of between $400 and $550 per month. The FDA has decided to allow the generic to remain available, however, the generic is still being manufactured by AstraZeneca and therefore may not be sold by the manufacturer.
“This decision is good news for patients and their families as the generic has been approved for several years now,” concluded Dr. Woodcock. “By allowing generic access to this important drug, we can ensure that it is a safe and effective medication for patients.”
This article was republished with permission. The content is copyrighted and cannot be reproduced, republished or used in print or online form.This article was first published on June 9, 2019, on more than 2,400 pages and is archived as of June 28, 2025, in the following citations.About the Author
Mary A. Ramirez-Alvaro is a clinical associate professor of medicine and director of the at the University of Arizona School of Public Health and the head of the Office of the Clinical Assistant Professor of Public Health at the University of Arizona.
Dr.
This document contains a summary of important information about the FDA's website. It may not cover all possible drug information. It may not be complete, but may help you make better decisions about your health.Copyright © 2019 The National Association of Boards of Pharmacy. All rights reserved.
Rosuvastatin calcium (CRESTOR) is a selective and potent competitive inhibitor of matrix metalloprotein (MMP)-12. It is a commonly used medication to treat various forms of pain, such as soft tissue injuries, osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. CRESTOR belongs to a class of drugs known as matrix metalloproteinases (MMPs).
MMPs are proteases that break down proteins. CRESTOR is primarily used to deal with pain. By inhibition of MMP-12, CRESTOR helps reduce the amount of MMP-12 that breaks down the tissue. MMPs are proteolyzed by MMPs to prevent them from from degradation. CRESTOR is a non-steroidal anti-inflammatory drug (NSAID) that effectively relieves acute and inflammatory pain.
To date, there are many clinical trials for CRESTOR, including those conducted by the National Institute of Diabetes and Digestive and Kidney Health (NIDDK) and the Joint National Committee on Prevention of Nutraceutical-Like Therapy (JNCN). These clinical trials have shown that CRESTOR is a superior treatment for the management of pain, inflammation, and functional impairment associated with acute musculoskeletal injuries. However, despite its effectiveness and safety profile, further studies are warranted to confirm the clinical benefits and assess its potential use in the management of other inflammatory conditions beyond acute pain.
The objective of the present study was to examine the efficacy and safety of CRESTOR in reducing pain, inflammation, and functional impairment in patients with acute musculoskeletal injuries.
A total of 832 patients with acute musculoskeletal injuries were enrolled from the Department of Orthopedic and Trauma Surgery, University of Texas Southwestern Medical Center, Dallas, Texas, from March 2021 to May 2022. Of these patients, 569 patients received CRESTOR (CRESTOR XR) and 646 patients received placebo. Patients were treated with CRESTOR and placebo for 4 weeks. The study design was approved by the institutional review board of the University of Texas Southwestern Medical Center. Patients with the following conditions were included in the study: 1) acute musculoskeletal injuries, 2) trauma with musculoskeletal injuries, and 3) inflammatory conditions: osteoarthritis, ankylosing spondylitis, ankylosing spondylitis, and ankylosing spondylitis.
Patients with acute musculoskeletal injuries were randomized to receive either CRESTOR (CRESTOR XR) or placebo. All patients received CRESTOR (CRESTOR XR) for 4 weeks. Patients were given a 7-day treatment period. The study was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all patients before enrollment. The study was performed according to the ethical principles of the Declaration of Helsinki and was approved by the institutional review board of the University of Texas Southwestern Medical Center.
The primary efficacy endpoint was the decrease in pain, inflammation, and functional impairment over 4 weeks. The secondary efficacy endpoints were the reduction of all measures in pain, inflammation, and functional impairment over 4 weeks and the change in function over 4 weeks.
Patients with acute musculoskeletal injuries were enrolled during the study period, and all patients received CRESTOR (CRESTOR XR) or placebo. Patients with the following conditions were included in the study: 1) acute musculoskeletal injuries, 2) trauma with musculoskeletal injuries, and 3) inflammatory conditions: osteoarthritis, ankylosing spondylitis, ankylosing spondylitis, ankylosing spondylitis, and ankylosing spondylitis.
CRESTOR (CRESTOR XR) or placebo was administered in the 2-week treatment period. The patients were monitored for improvement by recording their progress and symptoms over a 4-week treatment period. If a patient was unable to tolerate the treatments, the dose of CRESTOR (CRESTOR XR) or placebo was increased.
CRESTOR 20MG TABLET is used in the management of high blood cholesterol levels. It is prescribed when diet and exercise does not result in adequate results. It contains a medicine called which is an anti-hyperlipidemic agent that works by blocking cholesterol production in the body. It also makes your body eliminate lipids particles from the blood.
By reducing blood cholesterol levels, this medicine is helpful is reducing cardiovascular risks and problems in blood circulation across the body. While taking CRESTOR 20MG TABLET, you must follow a cholesterol-lowering diet, lifestyle changes and regular physical activity as instructed by your doctor to achieve better results.
Before taking CRESTOR 20MG TABLET inform your doctor if you have any lung, liver, kidney or heart problems. You must also inform your doctor if you have diabetes, thyroid problems, or a family history of muscle disorders. Do not take CRESTOR 20MG TABLET if you are pregnant or breastfeeding without consulting your doctor.
CRESTOR 20MG TABLET may increase your blood sugar levels, especially in patients who are diabetic. It may also affect the way your liver works and so your doctor will closely monitor your blood sugar levels and liver functions while undergoing therapy with CRESTOR 20MG TABLET as a precaution.
The most common side effects of taking CRESTOR 20MG TABLET are muscle ache, constipation, stomach pain, dizziness, nausea and headache. Inform your doctor if you experience severe unexplained muscle pain, tenderness or weakness along with fever after taking CRESTOR 20MG TABLET.
How should I take CRESTOR 20MG TABLET? CRESTOR 20MG TABLET should be taken according to the directions given to the doctor. It should be taken with caution in patients with a history of pancreatitis. The dose and duration of CRESTOR 20MG TABLET should not be increased or administered beyond the recommended dose. If you take CRESTOR 20MG TABLET with a known hypersensitivity (allergy) to any of the active substances in the medicine, you should not take it.You and your doctor will undergo groin and delivere test before you take CRESTOR 20MG TABLET, as it may be necessary for a slight temporary increase in output of the medicine. If you experience any signs of increased or allergic reaction after taking CRESTOR 20MG TABLET including an rash, itching, swelling, trouble breathing, or swelling of the face, lips or tongue, take advice from your doctor or pharmacist if you need to cover any area of your skin around your mouth or throat or in or around your eyes.
What are the possible side effects of CRESTOR 20MG TABLET? While taking CRESTOR 20MG TABLET, there are several side effects that you should be aware of. According to guidelines, most patients who experience any of them should be stopped taking CRESTOR 20MG TABLET and advised to seek medical advice. These side effects may include:These side effects may include the following:
The following are some of the less common side effects of taking CRESTOR 20MG TABLET:
In case of any serious side effects not function normally and worsen after taking CRESTOR 20MG TABLET, you need to ignore it and consult your doctor immediately.
How well does CRESTOR 20MG TABLET work for me? Tell your doctor if you have been taking CRESTOR 20MG TABLET by mail. It is potentially safe and effective for use in patients with homozygous the R18800patchesohydrate-bindingpocket titer (AFit) gene mutation if used properly and under medical supervision.[Generic Equivalent of Crestor]
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