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Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805

Activities Report of the Generic Drug Program | Fiscal Year 2024

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy designation under section 506H of the FD&C Act. The tables below provide data on the total number of ANDAs in these two categories that are either awaiting FDA action or awaiting applicant action at the end of each reporting quarter, as well as the number of ANDAs approved in each of these categories during the reporting quarter. The numbers reported below only reflect ANDAs that have been received for review pursuant to section 505(j) of the FD&C Act; if a new ANDA submission has not yet been received for review at the end of the reporting quarter, meaning FDA has not yet made a threshold determination whether the submission is substantially complete, it will be reported in the next quarter after it is received for review.

Section 805 of FDARA requires FDA to include in the reports under section 807 an annual report on the number of pending petitions under section 505(j)(2)(c) of the FD&C Act (commonly referred to as suitability petitions) and the number of such petitions pending a substantive response for more than 180 days from the date of receipt. This information is provided by fiscal year in the last table below.

Reports Available

NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems.

FY 2024 ANDAs Subject to Priority Review under Section 505(j)(11)* of the FD&C Act

  First Quarter Second Quarter Third Quarter Fourth Quarter
  October - December January - March April - June July - September
ANDAs Awaiting FDA Action 50 67 37 60
ANDAs Awaiting Applicant Action 42 39 67 40
ANDAs Approved 4 5 9 10

*The counts in this table include ANDAs that were subject to priority review under subparagraphs (A) and (D) of section 505(j)(11) of the FD&C Act, as added by section 801 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA).

FY 2024 ANDAs with a Competitive Generic Therapy Designation under Section 506H of the FD&C Act

  First Quarter Second Quarter Third Quarter Fourth Quarter
  October - December January - March April - June July - September
ANDAs Awaiting FDA Action 162 203 138 195
ANDAs Awaiting Applicant Action 148 146 210 136
ANDAs Approved 23 14 23 28
Number of Presubmission Meetings Requested 0 0 1 0
Number of Presubmission Meetings Held 0 0 0 0
Number of Product Development Meetings Requested 3 3 5 2
Number of Product Development Meetings Held 5 1 6 3

FY 2024 ANDAs with a Competitive Generic Therapy Designation under Section 506H of the FD&C Act for which the Secretary has taken action pursuant to Section 506H(c)*

  First Quarter Second Quarter Third Quarter Fourth Quarter
  October - December January - March April - June July - September
ANDAs Approved 0 1* 1* 2*

* Section 807(5) of FDARA requires FDA to include information in this report on the effect section 506H of the FD&C Act may have had on the length of time for approval and the number of review cycles for ANDAs with a CGT designation for which FDA has taken action pursuant to section 506H(c) of the FD&C Act. As FDA explained in the guidance for industry Competitive Generic Therapies, the actions FDA may take to expedite development include, as appropriate, product development meetings and pre-submission meetings, and the actions FDA may take to expedite review include mid-cycle-review meetings, enhanced mid-cycle-review meetings and striving to act on the ANDA as soon as possible, including prior to the GDUFA goal date.

To-date in FY 2024, there were four approved ANDAs for CGTs for which FDA took action to expedite the development and review of the applications; specifically, we granted the applicants product development meetings prior to submission of the ANDAs, granted two of the applicants a mid-review-cycle meeting during the first review cycle, and took actions to expedite the review of the four ANDAs.

It is difficult to assess the effect the actions to expedite the development and review of these CGTs may have had on the length of time to approval and the number of review cycles for approval without a larger sample of applications, including applications for comparable products for which expedited development and review actions were not taken to use as a comparison group. We note, however, that two of the ANDAs were approved after two or fewer review cycles and that the approval time for all four ANDAs was faster than the mean approval time for the quarter in which each ANDA was approved. Through our pre-ANDA program, the applicants for these ANDAs were able to receive targeted feedback on specific scientific issues or questions regarding their ANDA development program. The opportunity to obtain this kind of targeted advice from FDA likely shortened development time for the ANDAs and allowed the applicants to avoid deficiencies that may have led to a delay in the approval of the ANDAs.

FY 2024 Pending Suitability Petitions under Section 505(j)(2) (C) of the FD&C Act+

  FY 2024
Petitions Pending a Substantive FDA Response 107
Petitions Pending a Substantive FDA Response for More than 180 Days of Receipt 82**

+These numbers are reported annually and will be posted when available.

**Note that petitions submitted prior to FY 2024 did not receive goal dates.  Information about the performance of the generic drugs program on suitability petitions subject to goal dates, which began to apply for petitions submitted in FY 2024, will be included in annual GDUFA Performance Reports.

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