首页 > 资讯 > FDA9月仿制药批准数据 – OGD打破GDUFA后记录

出自识林

2015-10-01 Lachman CONSULTANTS

9月仿制药办公室（OGD）批准61件ANDA高调结束2015财年。之前完全批准量最高的一个月是2015年8月，当月OGD公布58件批准。9月OGD还公布了13件暂时批准，总批准行动为74件。

2015财年总完全批准量为492件，创下过去7年中批准量第二高记录。此前最高批准量的年份为2012财年，517件完全批准。

9月接收量将在几天之后才有最终统计结果，可能的是，如果OGD接收45件或更少的ANDA，今年的批准和接收将收支平衡或批准量超过接收量。

这一趋势会持续下去吗？我们当然希望如此。我们还希望看到完全回应函（CRL）数量每月增加，这意味着OGD正朝对的方向走上正轨。随着交流的增加，目标行动日期（TAD）的发布，所有这些都将超越GDUFA目标函的范围，我们绝对看到了OGD的努力。与此同时，我们必须保持警惕，以确保这些数字持续朝着正确的方向发展。

更多内容有待OGD发布接收和完全回复函数字后分析。

编译：识林-椒
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September 2015 ANDA Approvals – OGD breaks Previous Post-GDUFA Record
By Bob Pollock | September 30, 2015

The Office of Generic Drugs (OGD) approved 61 ANDAs in the month of September to close out fiscal year (FY) 2015 on a high note. The previous highest number of full approvals in a month was in August 2015 and, that month, OGD issued 58 approvals. OGD also issued 13 Tentative Approvals in the month, for a total of 74 approval actions for the month.

The total number of full approvals for FY 2015 hit 492 which is the second highest number of approvals issued in the past 7 years. The only FY with a higher number of approvals was in FY 2012 when OGD issued 517 full approvals.

The numbers of receipts will not be tallied for a few days but it is possible that, if OGD receives 45 or fewer ANDAs in September, it will either break even or approve more ANDAs than it received.

Is this trend going to continue? We certainly hope so. We also hope to see the number of Complete Response Letters (CRLs) increase each month, which will mean that OGD is really on track to be moving the freight in the right direction. With all of the increase in communications, issuance of Target Action Dates (TADs) all of which go beyond the confines of the GDUFA goal letter, we should absolutelty recognize OGD’s efforts. At the same time, we need to be vigilant to assure the numbers continue in the right direction.

More to come on receipts and CRLs as soon as OGD releases those numbers.