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出自识林

2015-02-07 Lachman CONSULTANTS

FDA网站“药品批准”页面 url已经更新，包括了到1月30日的ANDA批准（通过月度搜索原始简化新药申请 (ANDA)）。FDA数据库列出了1月份有22件ANDA批准，但请注意，其中9件是Valsartan市场专营期到期之后的申请。这大大低于过去两个财年和2015财年前3个月平均每月34件的批准量。

以2015财年第一季度平均每月38件ANDA的接收量计算，如果这一平均数量持续，接收量将继续超过批准量，这意味着积压将继续增长。现在我们当然（我们希望）在OGD效率的转折点，至少在有关批准的转折点，但我们仍在等待走出正在报导的这些数字的低谷。还记得2015财年到目前为止（第一季度），月平均完全回应函（CRL）的数量仅为每月71封 — 这一数字远低于2013财年的平均每月104封和2014财年的平均每月105封。

原始ANDA批准和接收这两个具体指标，显然是指示OGD进展的最大和最好指标，也是企业最关心的。然而，本财年到目前为止，我们没有看到任何补充数据（输入、CRL或批准）。因此，OGD工作量的总览有些模糊，而且这种模糊将持续到全部行动数据被报告并重新上线。

虽然我不喜欢花如此多的时间查看这些数字，并给出负面评论，但必须有人盯着这些数据并报告我们所看到的问题。谁又能比某个有FDA和行业视角，并且自1984年起就与这些数字打交道的人更合适呢？所以，至少在可见的将来，似乎我还会继续花时间在这些数字上。

Lachman CONSULTANTS - Bob Pollock先生 2015-02-04
编译：识林-椒 2015-02-07
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22 ANDA Approvals in January – Or So We Think!
Written by Bob Pollock • February 04, 2015

Well, it's February 4, 2015 and the “Drug Approvals” page on the FDA website appears to have been updated to include ANDA approvals through January 30 (search on Original Abbreviated New Drug Applications (ANDAs) by Month ( here). The FDA database lists 22 ANDAs approved in January, but remember that 9 of the 22 were for Valsartan after the expiration of an exclusive marketing period. This is substantially under the average of about 34 approvals per month seen in the last two fiscal years (FY), as well as the first three months of FY 2015.

With monthly ANDA receipts of about 38/month in the first quarter of 2015, if these average numbers continue, there will continue to be an excess of receipts over approvals, which means the backlog will continue to grow. Now, of course, we are in (what we hope) is the beginning of the turning point in OGD productivity at least with regards to approvals, but we still are waiting to turn the corner from the numbers that are being reported. Also remember that the average monthly number of Complete Response Letters (CRLs) is only 71 per month so far in 2015 (for the first quarter) - that number is down from averages of 104 and 105 per month respectively, in FY 2013 and 2014.

These two specific metrics, original ANDA approvals and receipts, are clearly the biggest and best indicators of OGD's progress and are of most interest to industry. However, we have not seen any data on supplements (incoming, CRLs or approvals) so far this FY, so the total picture of the OGD workload is and will be somewhat obfuscated until the full activity report data is reported and back on line.

While I do not like to spend so much time looking at these numbers and casting a negative twist on them, someone has to keep an eye on them and report what we are seeing. Who better than someone with an FDA and an industry perspective and someone who has lived these numbers since 1984? So, it appears that my time spent watching these numbers will continue, at least for the foreseeable future. If you see something in these numbers that I have not seen or if you have a different take on them, I would be interested to hear from you. Please let me know at r.pollock@lachmanconsultants.com