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2016-08-16 Lachman CONSULTANTS

FDA仿制药办公室（OGD）已发布其7月份的ANDA批准和接收数据。本财年到目前为止，OGD共批准548件原始ANDA，月平均批准54.8件。OGD表示批准量各个月有高有低，7月份批准46件ANDA成为本财年次低的月份（最低的是2016年1月，只有43件批准）。此外，7月份也是暂时批准量次低的月份，共10件暂时批准（之前最低的是2015年11月6件批准）。

Activities Report of the Generic Drug Program (FY 2016)

7月接收量为69件，2016财年10个月总接收量为733件，如果未来两个月按此提交速率发展预计总接收量为881件。以相同的批准率估计2016财年OGD的总批准量为656件。接收量和批准量之间的差距正在缩小，但仍然存在。随着GDUFA第五年审评目标收紧到10个月内完成90%，希望可以在批准方面看到更大的上涨。

完全回应函（CRL）继续以与过去几个月相同的步伐发布，共170封成为本财年第四高的月份（过去三个月分别是190、151和166封）。

总而言之，OGD提高了其在批准、暂时批准和CRL方面的输出。但企业的递交速率一直比批准率更高。应该更加集中注意力于首轮批准量（只有2014财年对最初两队列年提供了这一数据），这需要FDA和企业的共同努力。企业必须提高申请指南，FDA必须提高审评速度。2016年10月1日将开启GDUFA的第五年，届时将有到现在为止最为严格的审评时限。成败在此一举。

Lachman CONSULTANTS - Bob Pollock先生
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July 2016 ANDA Approvals and Receipts Numbers Announced
By Bob Pollock | August 11, 2016

The Office of Generic Drugs (OGD) released its July approval and ANDA receipt data today (here). So far this FY, OGD has approved 548 original ANDAs or a monthly average of 54.8 (easy to calculate since this is month 10 of the FY). OGD did say there would be good and bad months for approvals and the July number of 46 ANDA approvals is the second lowest this fiscal year (the lowest was 43 in January 2016). In addition, it was also the second lowest month for Tentative Approvals at 10 this month (previous lowest month was 6 in November 2015).

Receipts for the month stood at 69 and the total for the FY through 10 months stands at 733 with a straight line projection of 881 if the submission rate continues the same over the next two months. OGD can expect to approval 656 ANDAs during FY 2016 with the same approval rate. The gap between receipts and approvals is narrowing but still exists. Hopefully, GDUFA year 5 will see even a bigger uptick in approvals as the review goal tightens to 90% in 10 months.

Complete Response Letters continue at the about the same pace as last few months which registered the 4 highest number of CRLs this FY (190, 151, 166, and 170, respectively, over the last 4 months).

All-in-all, OGD has improved its output on approvals, tentative approvals and CRLs. But industry keeps the submission rate higher than the number of approvals. There certainly needs to be more concentration on first cycle approvals (data has only been made available for the first two cohort years of FY 2014) and that will take work on the part of both the FDA and industry. Industry must improve the quality of its applications and the FDA must improve the speed at which it can review applications. October 1, 2016 starts the 5th year of GDUFA with the most stringent review timelines of the program to date. This may be where the rubber meets the road.