Generic Rosuvastatin Calcium Approved by FDA

HealthDay News – The first generic version of rosuvastatin calcium tablets (Crestor; Watson Pharmaceuticals Inc., Parsippany, NJ) was approved Friday by the US Food and Drug Administration (FDA).

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, MD, 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.”


FDA approves first generic Crestor [news release]. Silver Spring, MD: US Food and Drug Administration; April 29, 2016.