首页 > 资讯 > FDA 2016财年8月ANDA批准数据

出自识林

2016-09-17 Lachman CONSULTANTS

FDA仿制药办公室（OGD）8月完全批准51件ANDA，暂时批准14件，总共65件批准行动。本月共接受59件新原始ANDA，低于本财年的月平均接收量72件（但请注意是由于本财年有两个月接收量拉高了平均值，12月180件和3月114件）。

Activities Report of the Generic Drug Program (FY 2016)

按此速率估算全财年预计总完全批准量为653件（显著超过2015财年492件的批准量，但已经比此前的预测稍低了一些），接收量为864件（超出2015财年的539件，但显著低于过去5年的平均值987件/年）。值得关注的一点是，当只考虑完全批准量时，OGD接收到ANDA仍然比批准量多，但如果将暂时批准考虑在内，差距大幅度缩小。根据目前速率估计，全财年接收量和完全批准量的差距大约为211件，而如果加上183件（按目前速率估计）暂时批准量，接收量和批准行动之间的差距将降低到28件。

8月份完全回应函的数量为166封，高于2016财年前11个月的月平均量140封，与过去5个月的增长保持一致。

OGD正在做得越来越好，但是现在仅剩一个月的时间就要开始GDUFA I期的第5年了，到时候对于2016年10月1日之后接收的原始申请的目标日期将从15个月变为10个月。祝OGD好运，并希望工业界同仁能够提供最优质的申请以协助OGD的努力。

Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
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August FY 2016 ANDA Numbers Out for Receipts and Approvals
By Bob Pollock | September 14, 2016 原文地址

OGD fully approved (AP) 51 ANDAs in August and tentatively approved (TA) 14 applications for a total of 65 approval actions for the month. Receipts of new original ANDAs was at 59 for the month, off of the monthly average of 72 (but remember, there were two big months that heightened that average).

Straight line full FY estimates for approvals are now at 653 (up significantly from FY 2015 approvals of 492, but have dropped a bit from earlier year predictions) and receipts straight line at 864 expected (up from 539 received in FY 2015, but down significantly from the running average of about 987/year over the last 5 years). One concern is that when you look at full approvals, OGD is still receiving more ANDAs than it approves, but if you factor in TAs, then the gap narrows considerably. The gap estimated between full FY receipts vs. approvals is at about 211 and with TAs projected to be at 183 for FY 2016 (applying a straight line approach to estimation) and call TAs “almost” approvals, the different between receipts and approval actions could be considered to be as low as 211 minus the 183 TAs or at +28.

Complete responses were at 166 for the month of August above the monthly average of about 140 seen in the first 11 months of FY 2016, and consistent with the increases noted over the last 5 months.

OGD is getting there and doing a good job, but is now less than one month away from the start of year 5 of GDUFA I, where the goal dates shift from 15 months to 10 months for originals received after October 1, 2016. Good luck OGD and let’s hope your industry colleagues provide the best quality applications to assist you in your efforts!