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  5. Activities Report of the Generic Drugs Program (FY 2019) | GDUFA II Quarterly Performance
  1. Generic Drug User Fee Amendments

Activities Report of the Generic Drugs Program (FY 2019) | GDUFA II Quarterly Performance

In section VI(C)(2) of the Generic Drug User Fee Amendments Reauthorization for Fiscal Years 2018-2022 (GDUFA II Commitment Letter), FDA committed to publishing quarterly metrics on its Website. The agency completes quarterly reporting in addition to the ongoing monthly and annual reporting that are part of Enhanced Accountability and Reporting under GDUFA II.

FY2019
  First Quarter
October - December		 Second Quarter
January - March		 Third Quarter
April - June

Fourth Quarter
July - September
ANDAs Awaiting FDA Action +, * 1865 1944 1803 1748
ANDA TAsAwaiting Applicant+, ** 428 422 430 438
ANDAs Awaiting Applicant Action +, *** 1689 1695 1742 1770
Mean AP Approval Time – Per Quarter ++ 32.12 35.42 35.20 31.99
Median AP Approval Time – Per Quarter ++ 22.21 24.43 26.89 23.13
Mean TA Approval Time – Per Quarter ++ 32.01 30.99 32.42 30.36
Median TA Approval Time – Per Quarter ++ 23.45 25.14 27.24 20.60

NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems. These numbers are not intended for Congressional reporting purposes. Additional metrics are available in the monthly activities report of the generic drugs program.

+ Abbreviated New Drug Applications (ANDAs) Awaiting FDA Action, ANDAs Awaiting Applicant TA, and ANDAs Awaiting Applicant Action represent a snapshot in time for the status of distinct original ANDAs. Many of these applications have been reviewed and found “not approvable” in a previous cycle and have been resubmitted by the applicant for another cycle of review and assessment. These metrics are calculated at the end of the Fiscal Year Quarter or just thereafter.

* ANDAs Awaiting FDA Action are applications currently being reviewed by FDA.

** ANDAs Awaiting Applicant TA are applications that have a status of ‘TA’ or Tentative Approval. If a generic drug product is ready for approval but cannot be approved due to a patent or exclusivity related to the reference listed drug product, FDA issues a tentative approval letter to the applicant, and the tentative approval letter details the basis for the tentative approval. A tentative approval does not allow the applicant to market the generic drug product. The Federal Food, Drug, and Cosmetic Act (FD&C Act) delays final approval of the generic drug product until all patent or exclusivity issues have been resolved or, in some cases, until a 30-month stay associated with patent litigation has expired.

*** Applications Awaiting Applicant Action are applications that have a status of ‘CR’ or Complete Response. These applications have been reviewed by FDA and the data submitted are inadequate to support approval.

++ Mean/ Median AP/TA Time is calculated as the difference between the first full approval (AP) date or the first Tentative Approval (TA) date and the date the original application was accepted for filing divided by the average number of days per month (30.4375). The unit for each of these metrics is months.

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