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2015-11-01 Lachman CONSULTANTS

FDA仿制药办公室开始以2015财年末相同的水平开启2016财年的审评工作，共批准72件ANDA，仅比9月的批准记录少2件，分别有51件完全批准和21件暂时批准（TA）。

虽然我相信企业希望看到更多完全批准，尤其是对于那些30个月审评时钟滴答作响最后仅获得暂时批准状态或失去180天专营期的风险的企业来说，这的确是受人欢迎的统计数字。这也可能与OGD极力推动为“最早的可能日期”实现最终批准来准备申请相关。清楚的是，这是Hatch-Waxman的目标之一，并且将为仿制药竞争做出贡献（仿制药更早获批上市）。随着最近美国国会和消费者在处方药价格上的获益，这对他们来说无疑是重大利好。

稍后我们将看到10月份的申请递交数量。2015财年OGD仅收到509件新的ANDA（平均每月大约提交42件），相比2014财年共接收1473件ANDA，也就是平均每月123件新递交的ANDA。我们希望能更好的了解递交放缓的一年，并希望OGD将借助这个间歇在减少旧申请的积压上取得一些进展，并合理使用时间超越2015财年GDUFA绩效目标。

Lachman CONSULTANTS - Bob Pollock先生 2015-10-31
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Another 70 Month for ANDA Approval Actions
By Bob Pollock | October 31, 2015 原文地址原文地址

11/02 update I just received an update for the October approval numbers from OGD and the full approvals have been revised upward from 49 to 51. That, coupled with the 21 tentative approvals (TA), actually sets the GDUFA approval actions record at 72 and all of these are in the first month of the first goal date year. Let’s hope this trend continues and good work, OGD!

The Office of Generic Drugs (OGD) is starting off FY 2016 at the same level that they ended FY 2015, with a total of 70 approval actions, one less than September’s record total. The breakdown is- 49 full approvals and 21 tentative approvals (TA).

While I am certain that industry would like to see more full approvals, for those in industry that have a 30-month clock ticking to obtain TA status or risk losing 180-day exclusivity, this number is certainly a welcome statistic. It may also be related to OGD’s push to have applications ready for final approval at the “earliest possible date.” Clearly, this is one the of Hatch-Waxman goals and would do wonders for competition. With all of the recent Congressional and consumer interest in prescription drug pricing, this has got to start to be music to their ears.

We hope to have submission numbers for you shortly. Remember that OGD only saw 509 new ANDAs submitted in FY 2015 (or an average of about 42 a month) compared to the 1473 ANDA, representing an average of almost 123 new ANDAs a month. We also hope to better understand the slow year for submission and hope that OGD will use this break in the action (if you can call it that) to make some headway in reducing the backlog of older applications and make the best use of its time to exceed the FY 2105 GDUFA goals.