首页 > 资讯 > ANDA增补成为FDA仿制药行动中的又一大山

出自识林

2015-03-31 Lachman CONSULTANTS

2015年2月仿制药行动报告url，除了增补数量大幅度增加外，其它各方面数据看起来与之前各月的报告非常相像。

上表显示了针对2015财年之前ANDA的增补数量，可以看出数字正逐渐恶化。2月总共有1100件针对2015财年之前申请的增补。假定这些是积压ANDA以及第一和第二年队列的增补，但定义并不完全清楚。底线是，企业正以更快的速度推进对之前提交申请的回复。另一件不是很明显的事情是，针对同一申请有几件增补提交。尽管如此，进入OGD审评计时的ANDA数量肯定会上升，这意味着ANDA积压一定达到了4000+的水平。

2015仿制药行动报告中公布的ANDA批准和暂时批准数量似乎仍与FDA每月公布的批准数量存在差异。例如，2月仿制药行动报告的批准和暂时批准分别是27件和13件，但FDA月度批准报告url列出的批准和暂时批准分别是21件和10件。看起来这些报告之间的脱节仍是问题。

下表展示了第3年队列申请已经收到了不断增长的增补，易更正缺陷和信息要求也开始出现在2015财年的原始提交中。这表明，OGD正在着手第三年队列的申请，并且开始公布回复情况。

现在的问题是，FDA如何处理2015财年之前申请的增补大量涌入，这些申请实际上没有GDUFA目标日期？所以，尽管OGD可能会因今年到现在为止较少的原始ANDA提交数量而借机喘口气，那些可能因2015财年原始ANDA提交下降产生的额外审评资源将很容易被大批涌来的增补消耗掉。

Lachman CONSULTANTS - Bob Pollock先生 2015-03-31
编译：识林-椒 2015-03-31
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Here Comes the Flood – Amendments are the Next Mountain to Climb for OGD
Written by Bob Pollock • March 31, 2015

The February 2015 Generic Drugs Activity Report looks much like the previous month’s report except for the number of amendments seen flying into the Office of Generic Drugs.

The above chart shows amendments coming in for pre-FY 2015 ANDAs, and, as you can see, the numbers are going off the charts. A total of about 1100 amendments for pre-2015 applications came in this month. These are presumed to be backlog ANDAs and cohort year one and two amendments, but the definition is not entirely clear. The bottom line is that industry is pushing in responses to previously submitted applications at a faster pace. The other thing that is not evident is how many of the amendments may be submitted to the same application. Nonetheless, the number of ANDAs coming back onto the OGD clock must be going up, which means the ANDA backlog (as I define it, as work that OGD has on its plate) must be reaching the 4000+ level.

There also still seems to be a discrepancy in the numbers of ANDAs approved and tentatively approved as reported in the Generic Drugs Activity Report for 2015 and the FDA monthly approvals posted. For instance, approvals and tentative approvals from the February Generic Drugs Activity Report are reported as 27 and 13, respectively, but the FDA Monthly Approval Report list approvals and tentative approvals as 21 and 10. Looks like the disconnect between these reports is still a problem.

The chart below shows that cohort year 3 applications are already receiving an increase number of amendments and the Easily Correctible Deficiency and Information Requests are starting to show up for the FY 2015 original submissions. This shows that OGD is attacking the cohort year three applications, and responses are beginning to flow in.

The question is how does the Agency handle the large influx of the pre-FY 2015 amendments, as these applications actually have no GDUFA goal dates? So, while OGD may get a break with the lower number of original ANDA submissions so far this year, the number of amendments pouring in will easily eat up any excess review resources that may have been realized through the dip in the original ANDAs submissions thus far in FY 2015.