全球仿制药巨头梯瓦Teva4月8日宣布FDA批准Lovaza仿制药（omega-3脂肪酸乙酯）胶囊。Teva声称自己是首个向FDA提交Lovaza仿制药上市申请并获得批准的公司。
Lovaza是葛兰素史克的一款重磅降甘油三酯药物，2013年销售额为9.17亿美元，其中9.12亿美元来自美国市场。
Teva launches first generic Lovaza in USA
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 (The Pharma Letter September 13, 2013). |
