Mylan Inc. has been cleared to market fluvastatin capsules, a treatment for high cholesterol.


Mylan, fluvastatin capsules, Lescol, generic version, Mylan Pharmaceuticals, Novartis, pediatric exclusivity, high cholesterol, hypercholesterolemia, dyslipidemia, cardiovascular disease










































































































































































































































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Mylan ships Lescol generic version

April 16th, 2012

PITTSBURGH – Mylan Inc. has been cleared to market fluvastatin capsules, a treatment for high cholesterol.

The company said Friday that its Mylan Pharmaceuticals Inc. subsidiary has received final approval from the Food and Drug Administration for its abbreviated new drug application (ANDA) for fluvastatin capsules in strengths of 20 mg and 40 mg

According to Mylan, the product is the first generic version of Novartis' Lescol Capsules, indicated for the treatment of familial and nonfamilial hypercholesterolemia and mixed dyslipidemia, as well as the secondary prevention of cardiovascular disease.

Mylan said that, under a settlement and license agreement with Novartis, it was granted a license permitting the product launch before the expiration of the pediatric exclusivity on June 12, 2012.

Lescol capsules had U.S. sales of about $27.9 million for the 12 months ended Dec. 31, according to IMS Health data cited by Mylan.

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