FDA approves first Crestor generic

SILVER SPRING, Md. — The Food and Drug Administration on Friday announced that it had approved a generic of AstraZeneca’s Crestor (rosuvastatin calcium). The generic, from Allergan, is the first to be approved for blockbuster Crestor, which saw $6.5 billion in annual sales for the 12 months ended March 31, according to IMS health. 

 

The drug is indicated to treat high triglycerides, dysbetalipoproteinemia and high LDL cholesterol. It was approved in 5-, 10, 20-, and 40-mg dosage strengths, according to the FDA. 

 

“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,” said Dr. Kathleen Uhl, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

 

In 2013, Actavis said it would launch its generic 67 days before July 8  — the day that Crestor’s pediatric exclusivity expires.