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梯瓦推出希罗达(Xeloda)仿制药

新药编辑:新特药 更新时间:2015-04-12

2014年3月8日讯/tumor.net.cn/--仿制药巨头梯瓦(Teva)3月7日宣布,在美国推出Xeloda(希罗达,capecitabine,卡培他滨,150mg和500mg片剂)等效仿制药。Xeloda品牌药由罗氏旗下基因泰克(Genentech)销售。梯瓦Xeloda仿制药简化新药申请(ANDA)于2013年9月获FDA批准,是首个拿到批文的制药公司。

根据IMS数据,截止2013年12月,Xeloda品牌药(150mg和500mg片剂)在美国的销售额为7.54亿美元。

Xeloda是FDA批准的首个口服化疗药物,属于氟代嘧啶氨基甲酸酯类药物,是细胞周期特异性抗代谢类药物,药物进入人体经脱氧胞嘧啶酶激活后,由胞嘧啶核苷脱氨酶代谢为5-氟尿嘧啶(5-FU)。5-氟尿嘧啶作用于DNA合成期的肿瘤细胞,在一定条件下,可以阻止癌组织细胞分裂增生。

Xeloda于1998年获FDA批准,该药用于结直肠癌、胃癌、乳腺癌的治疗。Xeloda的美国专利于2013年12月14日到期。(tumor.net.cn)

英文原文:Teva Announces Launch of Generic Xeloda? Tablets 150 MG and 500 MG in the United States

ERUSALEM--(BUSINESS WIRE)--Mar. 7, 2014-- Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announces the launch of the generic equivalent to Xeloda? (Capecitabine) Tablets, 150 MG and 500 MG, in the United States. Xeloda? is marketed by Genentech in the United States. Teva was the first to receive approval on its ANDA from the U.S. Food and Drug Administration on September 16, 2013 and is launching today per a settlement agreement.

Xeloda? (Capecitabine) Tablets, 150 MG and 500 MG had annual sales of approximately $754 million in the United States, according to IMS data as of December, 2013.

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's Specialty Medicines businesses focus on CNS, respiratory oncology, pain, and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.

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