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2014-06-18 Lachman CONSULTANTS

大潮袭来前的小浪花 — 5月接收134件ANDA

正如12月份的新药申请数目一样典型，2014年5月的134项申请仅为“大”6月的沧海一粟（我们如此认为）。记住，2014年6月20日，新的稳定性法规实施前，公司将争先恐后地将他们的ANDA递交上去。

我上周的报告中指出，仿制药办公室（OGD）5月份仅批准了20件ANDA，然而，从FDA网站上整个5月份的数据来看，我可以告诉你OGD同时拒绝接收了20件ANDA，是本财年拒收数目第二多的月份（2013年12月拒收30件）。

现在，本财年已经过去8个月，这段时间内，OGD已经收到805件ANDA。除了上文提到的6月，预计还有另一个申请大月， 那就是9月份，大家都将赶在费用增高（除非由于ANDA提交始料未及的增多而导致费用下降）。如果费用确实下降，在GDUFA第三年的指标，以及自己的申请有可能成为15个月内审评的60%ANDA中的一员这样的诱惑下，企业可能会等到9月份。新的收费标准很快就会出来，跟进这一问题看看它将如何影响申请数目，这是件有趣的事情。

如果我们简单地线性考虑前8个月收到的805件ANDA，那么全财年的申请数目将略微超过1200件——创造新纪录的同时，也面临很多全新的挑战！

Lachman CONSULTANTS - Bob Pollock先生 2014-06-16
校译：识林-柯 2014-06-18

The Blip Before the Blip – 134 ANDAs Received in May
Written by Bob Pollock • June 16, 2014

Looking more typical of a December number of ANDA submissions, the May 2014 number of 134 is just a blip before (what we believe will be) a very big June. Remember that firms will be hustling to get ANDAs in before the new stability requirements go into effect on June 20, 2014.

I reported last week that the Office of Generic Drugs (OGD) only approved 20 ANDAs in May; however, with the posting of the full May statistics on the FDA website, I can also tell you that OGD refused to receive 20 ANDAs, the second most in any month this fiscal year (30 in October 2013).

Now we are 8 months into this fiscal year and already OGD has received 805 ANDAs in that period. We have another big month (as noted above) expected in June, then there will be the September rush to beat the fee increases (unless the fees dip due to an unexpected increase in ANDA submissions). If the fees do decline for ANDAs, and, with a lure of year three metrics and perhaps being one of the 60% of the ANDAs reviewed within 15 months, firms may decide to hold off in September for that chance. The new fees will be out soon and it will be interesting to follow that issue and see how it impacts submissions.

If we simply straight-line the first 8 months receipts of 805 ANDAs, then expect the full fiscal year’s submissions to be just a little over 1200 ANDAs – a new record at a time of many new challenges!

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