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2016-02-02 Lachman CONSULTANTS

华盛顿特区和马里兰地区的灾难性暴风雪引起联邦政府几天的关闭可能导致2016年1月ANDA批准的下降。FDA仿制药办公室（OGD）1月完全批准42件ANDA，暂时批准17件ANDA。

2016财年已经过去4个月，OGD平均每月批准58件ANDA，这显著高于迄今为止任一GDUFA财年的月平均批准量。以这个月的批准率，在GDUFA计划第四年末OGD应实现接近700件的批准量。之前GDUFA后ANDA批准量最多为2015财年的492件。如果这是下降的月份，我们可能会看到比对目前趋势的直接预测更多的批准。

2016财年4个月OGD平均每月有17件暂时批准（TA），这也超过了GDUFA第1年到第3年月平均暂时批准量。这是个好消息，因为TA通常可以转化为批准。本月接收量的最终数据还没有公布，我们将在OGD公布后立刻更新。

正如我之前曾提到的，2016财年似乎有着很大改善，但随着步入GDUFA II期谈判的核心，会有足够的改善以满足仿制药企业？

Lachman CONSULTANTS - Bob Pollock先生
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January's Big Chill Places Some Strain on Approval Actions
By Bob Pollock | February 1, 2016

The Washington DC. / Maryland “snowmageddon” event causing the closure of the Federal Government for a few days may have resulted in a dip in ANDA approvals in the first month of calendar year 2016. The Office of Generic Drugs (OGD) fully approved 42 ANDAs and tentatively approved 17 ANDAs in January.

Four months into FY 2016, OGD is averaging 58 approvals a month, which is significantly higher than in any of the GDUFA FYs to date. At this monthly rate of approvals, OGD should hit close to 700 (696 to be exact) by the end of year four of the GDUFA program. The previous high for post-GDUFA ANDA approvals was 492, which came in FY 2015. Hopefully, if this is a down month, we may see even more that the straight line projection predicts.

OGD has been averaging about 17 Tentative Approvals (TA) a month, which is also at a pace that exceeds what we have seen in years 1-3 of the program. This is good news since TAs usually translate into approvals.

The final number of receipts were not yet available for publishing, but will be reported upon as soon as that number is reported by OGD.

Take care when reviewing the Generic Drugs Activity Report for FY 2016 online, as the totals column only totals the first two months of activity. (I guess OGD may be spending more time on review and approval activities than monitoring the reporting of their activity.) This can also be seen in the lack of data on many of the categories of the metrics OGD has previously reported. For instance, while Changes Being Effected (CBE) supplements are reported for the first two months of the FY, they are not provided for month three (December). It is interesting to note that the number of CBE supplements fell by almost 50% in November (373) as compared to 625 in October. FY 2015 saw an average of about 460 CBE a month, which is close to where the reported two-month average sits now.

As I noted previously, FY 2016 appears to be a big improvement, but will it be enough of an improvement to satisfy the generic drug industry as they move into the meat of negotiations for GDUFA II?