FDA Approves First Generic of Crestor
The FDA has approved the first generic version of rosuvastatin calcium (Crestor).
(HealthDay News) — The first generic version of Crestor (rosuvastatin calcium) tablets was recently approved by the 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. FDA website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm498373.htm. April 29, 2016. Accessed May 2, 2016.