FDA批准首个卡培他滨仿制药

美国食品药品管理局(FDA)9月16日宣布，于1998年获准用于治疗转移性乳腺癌的卡培他滨，如今将有仿制剂型可供选择。

FDA在一份书面声明中指出，已批准了美国梯瓦制药公司生产的仿制型卡培他滨(150 mg和500 mg)，这是首个获准的卡培他滨仿制药。

卡培他滨还获准用于治疗转移性结直肠癌(2001年)和Dukes C期结肠癌(2005年)。它是一种具有抗肿瘤活性的核苷代谢抑制剂，由基因泰克公司以商品名“希罗达”销售。点击此处可查看该药的说明书。

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By: ELIZABETH MECHCATIE, Internal Medicine News Digital Network

Capecitabine, first approved for treating metastatic breast cancer in 1998, now will be available in a generic formulation, the Food and Drug Administration announced Sept. 16.

The FDA has approved generic capecitabine (150 mg and 500 mg), manufactured by Teva Pharmaceuticals USA, the first generic formulation of this drug to be approved, the agency said in a written statement.

Capecitabine also has been approved for treating metastatic colorectal cancer (2001) and Dukes’ C colon cancer (2005). It is a nucleoside metabolic inhibitor with antineoplastic activity, and the trade formulation is marketed by Genentech as Xeloda.

To view the label for the trade formulation, click here.

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