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Come from:Shandong Caman Biotech Co., Ltd. Class:News Date:2019/12/3 浏览统计:532

Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) says it has received US Food and Drug Administration approval of the generic equivalent to Lovaza (omega-3-acid ethyl esters capsules, USP.

Teva, the world’s largest generic drugs maker, believes it is first-to-file and thus far is the only company to receive an approval from FDA. The company added that it plans to commence shipping the triglyceride lowerer immediately.

Lovaza, marketed by UK pharma giant GlaxoSmithKline (LSEP GSK), had annual sales of around $1.1 billion in the USA, according to IMS data as of December 2013 quoted by Teva.

Last year, the US Court of Appeals for the Federal Circuit cleared the way for generic versions of Lovaza ruling that both Teva and Par Pharmaceuticals (NYSE: PRX) can go ahead with plans to launch generic copies of Lovaza.