FDA Approves First Generic Crestor

Allergan’s rosuvastatin calcium joins a $6.5 billion market

The FDA has approved the first generic version of Crestor tablets (rosuvastatin calcium, AstraZeneca), which will be marketed by Allergan in 5-, 10-, 20-, and 40-mg strengths.

The drug is approved for use in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults; in combination with diet for treatment of patients with primary dysbetalipoproteinemia (type-3 hyperlipoproteinemia), a disorder associated with improper breakdown of cholesterol and triglycerides; and either alone or in combination with other cholesterol treatment(s) for adult patients with homozygous familial hypercholesterolemia, a disorder associated with high low-density lipoprotein-cholesterol (LDL-C).

High LDL-C, the so-called “bad cholesterol,” is a known risk factor for heart attacks, strokes, and heart disease. High triglycerides may also increase the risk of heart disease.

Rosuvastatin calcium is in a class of drugs called statins, which work by stopping an enzyme called HMG-CoA reductase from making cholesterol. Statins should be used in addition to a diet restricted in saturated fat and cholesterol.

In the clinical trials for Crestor, the most common side effects reported by participants included headache, pain in muscles (myalgia), abdominal pain, abnormal weakness (asthenia), and nausea.

Rosuvastatin calcium should not be used in women who are pregnant or may become pregnant as it may cause fetal harm. Women who require treatment with rosuvastatin should be advised not to nurse their infants.

Under the terms of an agreement reached with AstraZeneca on March 25, 2013, Allergan launched its generic version of Crestor 67 days prior to July 8, 2016, the expiration of exclusivity. Allergan predicted that this will be the largest generic launch of 2016.

For the 12 months ending March 31, 2016, Crestor had total U.S. brand sales of approximately $6.5 billion, according to IMS Health data.

Sources: FDA; April 29, 2016; and Allergan; May 2, 2016.