Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
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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!
