Generic Crestor Approved by FDA

Share this content:
Generic Crestor Approved by FDA
Generic Crestor Approved by FDA

FRIDAY, April 29, 2016 (HealthDay News) -- The first generic version of Crestor (rosuvastatin calcium) tablets was approved Friday by the U.S. Food and Drug Administration.

Watson Pharmaceuticals Inc. of New Jersey received approval to market generic rosuvastatin calcium in multiple strengths for certain uses.

These uses include: in combination with diet for the treatment of hypertriglyceridemia in adults, in combination with diet for treatment of patients with primary dysbetalipoproteinemia (type III hyperlipoproteinemia), and either alone or in combination with other cholesterol treatment(s) for adult patients with homozygous familial hypercholesterolemia.

"The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments," Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, said in a statement. "The FDA requires that generic drugs meet rigorous scientific and quality standards."

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Drug Lookup

Browse drugs by: BrandGenericDisease

Trending Activities

All Professions



Sign up for myCME e-newsletters




More in Home

FDA Approves Palynziq for Phenylketonuria

FDA Approves Palynziq for Phenylketonuria

Drug is a novel enzyme therapy for adult patients with PKU with uncontrolled blood Phe concentrations

Increase in Tx Candidates With 2017 Hypertension Guidelines

Increase in Tx Candidates With 2017 Hypertension Guidelines

Increase in proportion of adults recommended for treatment; estimated decrease in CVD events, deaths