SILVER SPRING, MD — Widely prescribed rosuvastatin (Crestor, AstraZeneca) is joining the crowded field in the US of generically available statins[1]. Today the Food and Drug Administration approved a generic version of rosuvastatin calcium in several pill strengths for marketing by Actavis (formerly Watson Pharmaceuticals, the name used by the agency).
The approved indications are specified as "in combination with diet for the treatment of [hypertriglyceridemia] in adults; in combination with diet for treatment of patients with primary . . . type 3 hyperlipoproteinemia; either alone or in combination with other cholesterol treatment(s) for adult patients with homozygous familial hypercholesterolemia."
Interestingly for the dyslipidemia-drug playing field, Merck's patent on the nonstatin cholesterol-lowering agent ezetimibe (Zetia) is also due to expire this year. But as a class, statins have been among the most widely prescribed drugs in history.
Rosuvastatin is going generic and presumably plunging in price, at a time when clinicians overall have been lukewarm about prescribing the recently approved but comparatively expensive proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors alirocumab (Praluent, Sanofi/Regeneron Pharmaceuticals) and evolocumab (Repatha, Amgen).
Those agents have as yet demonstrated their mettle in large randomized trials primarily for the surrogate end point of LDL-C reduction. Large mortality trials for those agents are ongoing and may have a lot to say about whether the PCSK9 inhibitors become more widely used.
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Cite this: FDA Approves Generic Rosuvastatin (Crestor) - Medscape - Apr 29, 2016.
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