FDA approves generic versions of Crestor

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The FDA approved generic versions of rosuvastatin calcium (Crestor) on July 21, one day after a federal judge denied AstraZeneca’s request to extend its exclusivity for the best-selling cholesterol-lowering medication.

Several companies will now be allowed to sell generic rosuvastatin calcium, including Mylan, Sun Pharma and Sandoz.

For the 12 months ending in May 2016, sales of rosuvastatin calcium were approximately $6.7 billion, according to IMS Health. A New York Times article mentioned the brand-name version of the drug has a retail price of $260 per month, while the generic versions could sell for 80 percent to 90 percent less.

In May, the FDA approved rosuvastatin calcium for children with homozygous familial hypercholesterolemia and granted the company seven years of market exclusivity for that condition. The company then petitioned the FDA and asked to extend the exclusivity for all indications of the medication.

On July 7, Senator Bernie Sanders and seven Democrats from the House of Representatives sent a letter to FDA commissioner Robert M. Califf, MD, requesting the agency to approve generic versions of rosuvastatin calcium.