Wockhardt receives US FDA approval for cancer drug

达珂仿制药 Wockhardt 获得美国 FDA 癌症药物审批

2019-04-12 19:10:41 PHARMACEUTICAL


Wockhardt’s Decitabine Injection is a generic version of Dacogen, marketed in USA and other countries by Otsuka. Decitabine is used to treat Myelodysplastic syndromes (MDS), a group of cancers in which immature blood cells in the bone marrow do not mature and therefore do not become healthy blood cells. According to IQVIA February 2019 data, the product has sales of $120 million in the US. “This is the third US FDA approval for an oncology product for Wockhardt during the past three months, and has added to our growing portfolio of cancer drugs” said Dr. Habil Khorakiwala, Founder Chairman, Wockhardt Group. “Wockhardt has been sustaining growth in the US and worldwide through an increasing portfolio of specialty products including oncology drugs” he said. Wockhardt will be launching this product in the United States, in a short period of time. With its nationwide distribution network and its excellent relationship with all major trade, retail and institutional customers, Wockhardt is already a significant player in the US pharmaceutical market. The product is being manufactured at a contract manufacturing facility, based near Hyderabad, India. Source: Company Press Release
沃克哈特的卡地平注射液是达可待因的仿制药,在美国和其他国家由大冢(Otsuka)公司销售。 卡地平用于治疗骨髓增生异常综合征( MDS ),一组肿瘤,骨髓中不成熟的血细胞不成熟,因此不能成为健康的血细胞。根据 IQVIA 2019年2月的数据,该产品在美国的销售额为1.2亿美元。 Wockhardt 集团创始人董事长 Habil Khorakiwala 博士说:“这是过去三个月来美国 FDA 第三次批准 Wockhardt 的肿瘤治疗产品,也增加了我们不断增长的癌症药物组合。”他表示:“沃克哈特通过不断增加的包括肿瘤药物在内的特色产品组合,一直在美国和全球保持增长。” 沃克哈特将在短期内在美国推出该产品。沃克哈特凭借其覆盖全国的分销网络以及与所有主要贸易、零售和机构客户的良好关系,已经成为美国医药市场的重要参与者。 该产品正在印度海得拉巴(Hyderabad)附近的一家合同制造工厂生产。 资料来源:公司新闻稿