Mylan Launches Generic Version of Novartis’ Lescol

Mylan launched a generic version of Novartis’ extended-release Lescol following FDA approval of its ANDA for the cholesterol drug.

The fluvastatin 80 mg sodium tablets are indicated to reduce elevated total cholesterol, LDL-C, Apo B and triglyceride, and increase HDL-C in adults with primary hypercholesterolemia and mixed dyslipidemia, the company said last week.

The treatment is intended as an adjunct to diet when there is an inadequate response to diet and other non-pharmacological treatments, such as weight reduction and exercise.

Fluvastatin sodium XR tablets had annual U.S. sales of roughly $37.6 million as of June 30, according to IMS Health.

Mylan had launched 20 mg and 40 mg fluvastatin capsules in April 2012. — Jonathon Shacat