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迈兰推出Paraplatin(伯尔定注射液)仿制药

来源:生物谷 2014-06-10 09:08

2014年6月9日讯 /生物谷BIOON/ --迈兰(Mylan)6月9日宣布,在美国推出卡铂注射液(Carboplatin Injection,50mg/5ml),该药是百时美施贵宝(BMS)品牌药Paraplatin Injection(伯尔定注射液,Carboplatin Injection)的仿制药,适用于与其他已获批的化疗药物组成现有的治疗方案,用于晚期卵巢癌的初始治疗。此外,卡铂注射液(150mg/15ml,450mg/45ml,600mg/60ml)也已获FDA批准。迈兰计划接下来陆续将这些产品推向市场。

根据IMS Health数据,截止2014年3月31日,卡铂注射液(150mg/15ml,450mg/45ml,600mg/60ml)在美国的年销售额约为3040万美元。目前,迈兰有299个简化新药申请(ANDA)正在等待FDA批准,这些产品所针对的品牌药年销售额达1052亿美元。这299个ANDA中,有41个有望成为首个提交的ANDA,所针对的品牌药年销售额为254亿美元。(生物谷Bioon.com)

英文原文:Mylan Launches Generic Paraplatin® Injection

PITTSBURGH, June 9, 2014 /PRNewswire/ -- Mylan Inc. MYL -0.62%  today announced that it has launched Carboplatin Injection, 50 mg/5 ml, in multi-dose vials, which is the generic version of Bristol-Myers Squibb's Paraplatin® Injection. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. Mylan also received final approval for Carboplatin Injection, 150 mg/15 ml, 450 mg/45 ml, 600 mg/60 ml, in multi-dose vials, and intends to launch these presentations subsequently.

Carboplatin Injection, 50 mg/5 ml, 150 mg/15 ml, 450 mg/45 ml, and 600 mg/60 ml had U.S. sales of approximately $30.4 million for the 12 months ending March 31, 2014, according to IMS Health. This launch bolsters Mylan's growing portfolio of cancer treatment and supportive care products.

Currently, Mylan has 299 ANDAs pending FDA approval representing $105.2 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2013, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it.

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