首页 > 资讯 > FDA 2016财年2月ANDA批准数据

出自识林

2016-03-03 Lachman CONSULTANTS

更新：

原始ANDA的批准和接收是OGD必须平衡的阴阳面，但OGD仅对批准具有控制权。2月共接收62件原始ANDA，是2016财年提交量第二高的月份。这与12月180件的提交量相比相形见绌，但仍表明一个事实，今年OGD可期待比去年更多的申请提交。

到目前为止，本财年OGD平均每月接收71.4件ANDA。对该平均数采用直线规划法本财年将产生约857件ANDA，比2015年接收量多出248件。857件（尽管比过去5年间的平均量低）仍高于FDA对GDUFA第1-5年估计的750件预期数量。

2015年较低的接收量（509件）给了OGD一些喘息的空间来处理在GDUFA计划前3年里巨大的接收量。OGD能继续如预计的那样消化吸收这些申请并不断满足GDUFA目标吗？我敢肯定他们能够而且必须这样做，因为他们不仅向企业，也向国会这样承诺。真正的问题是，在满足GDUFA目标上需要花费什么资源，积压和GDUFA第1年和第2年的提交是否将收到影响？只有时间会告诉我们一切。

FDA仿制药办公室二月完全批准51件ANDA，暂时批准12件。鉴于二月是较短的月份，虽然今年是闰年，OGD的批准量与本财年过去的表现相一致。事实上，本财年前5个月，二月份51件ANDA完全批准是第三高的月份，而总共63件批准行动在2016财年（GDUFA第4年）已经过去的5个月中排在第四。

OGD本财年目前平均每月57件完全批准，以此估计全年完全批准总计682件。这与2015财年每月41件的批准量和2014财年每月34件，以及2013财年每月37件（GDUFA I期第一年）。所以当看到整个GUDFA生命周期中的批准量，OGD本财年的表现一直在变得更好（至少在最终产出 - 即批准量方面）。

至于暂时批准，OGD目前平均每月15.4件，直线估计一年约有185件暂时批准。当申请在其它方面符合批准时，如果没有或仅有微小变化，暂时批准在大多数情况下会毫不费力的转变为完全批准。

鉴于上周在GPhA年会上企业表达的焦虑，这些数字能否平息仿制药企业领导的忧虑？我的看法是他们正在从新建立的GDUFA机器中寻求更加高效的批准！

Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
识林^®www.shilinx.com版权所有，未经许可不得转载。如需使用请联系admin@shilinx.com

OGD February Approval Numbers Are In!
By Bob Pollock | March 1, 2016

The Office of Generic Drugs (OGD) fully approved 51 ANDAs and tentatively approved 12 ANDAs this past month. Given that February is a short month (albeit this is a leap year), OGD approval numbers are consistent with past performance so far this fiscal year. As a matter of fact, of the first 5 months of this fiscal year, the approval of 51 ANDAs represents the third highest number of ANDAs fully approved in a given month, while the total approval actions of 63 is fourth out of the five months of FY 2016 year (GDUFA year 4).

OGD is currently producing an average of about 57 full approvals a month this fiscal year, which could translate to a total of 682 approvals for the year. This compares with approval rates of 41/month in FY 2015, 34/month in FY 2014 and 37/month in FY 2013 (the first year of GDUFA I). So when you look at the approval output over the life of GDUFA, OGD is performing consistently better so far this year (at least in terms of the ultimate output, which is approvals).

As far as tentative approvals go, OGD is averaging 15.4 a month, which (straight lines) would be a total of about 185 tentative approvals a year. Remember that TA can, in most cases, convert to full approvals with little effort, if there are no or only minor changes made when the application is otherwise eligible for approval.

We will take a look at ANDA receipts, hopefully, tomorrow when those numbers are available.

Given the industry angst expressed at the GPhA Annual meeting last week, are these numbers going to appease the leaders of the generic industry? My view is that they are looking for more approval production from the newly built GDUFA machine!