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迈兰推出炔诺酮片仿制药

来源:生物谷 2013-07-17 02:21

2013年7月17日讯 /生物谷BIOON/ --迈兰(Mylan)7月16日宣布,其美国子公司迈兰制药(Mylan Pharmaceuticals)在美国推出炔诺酮片(Norethindrone Tablets USP, 0.35 mg),该药为阿特维斯(Actavis)NorQ.D片(0.35mg,28天为一周期)的仿制药。

根据IMS数据,截止2013年3月31日,炔诺酮片(0.35mg)在美国的年销售额约为3900万美元。(生物谷Bioon.com)

英文原文:Mylan Launches Generic Nor-Q.D.? Tablets, 0.35 mg (28-Day Cycle)

PITTSBURGH, July 16, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Norethindrone Tablets USP, 0.35 mg. Norethindrone Tablets USP, 0.35 mg, are the generic version of Watson Laboratories' (now Actavis, Inc.) Nor-Q.D.? Tablets, 0.35 mg (28-Day Cycle), which are indicated for the prevention of pregnancy. Mylan's partner, Famy Care Ltd., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.

Norethindrone Tablets USP, 0.35 mg, had U.S. sales of approximately $39 million for the 12 months ending March 31, 2013, according to IMS Health.

Currently, Mylan has 174 ANDAs pending FDA approval representing $83.2 billion in annual sales, according to IMS Health. Thirty-six of these pending ANDAs are potential first-to-file opportunities, representing $22.9 billion in annual brand sales, for the 12 months ending Dec. 31, 2012, according to IMS Health.

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