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

Fiscal Year 2021

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 2021 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 54 58 59  
ANDAs Awaiting Applicant Action 18 19 25  
ANDAs Approved 6 10 4  

*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).

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FY 2021 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 114 129 132  
ANDAs Awaiting Applicant Action 53 55 76  
ANDAs Approved 14 15 10  
Number of Presubmission Meetings Requested 0 0 0  
Number of Presubmission Meetings Held 0 0 0  
Number of Product Development Meetings Requested 4 4 6  
Number of Product Development Meetings Held 7 5 5  

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FY 2021 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* 0  

* 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-review-cycle meetings and striving to act on the ANDA as soon as possible, including prior to the GDUFA goal date.

In the second quarter of FY 2021 there is one approved ANDA for a CGT for which FDA took action to expedite the development and review of the application; specifically, we held a product development meeting with the applicant prior to submission of the ANDA, held a mid-review-cycle meeting during the first review cycle, and acted on the ANDA prior to its GDUFA goal date. This CGT is a complex product (as defined in the GDUFA II Commitment Letter) for which FDA had not issued a product-specific guidance at the time the product development meeting was held, qualifying the applicant for our pre-ANDA program. This program, which was established under the Generic Drug User Fee Amendments of 2017, has a special focus on complex generic drug products, which can be more challenging for generic drug developers to copy, often leading to a lack of generic competition even after patents and exclusivities no longer block generic drug approval.

It is difficult to assess the effect the action to expedite the development and review of this CGT 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 despite the complexity of this CGT product, the ANDA was approved after two review cycles approximately one year after it was submitted, which is faster than the mean and median approval times for the quarter in which it was approved. Through our pre-ANDA program, the applicant was able to receive targeted feedback on their proposed bioequivalence approach as well as targeted advice on product development and quality control study questions, which likely shortened development time for the ANDA and allowed the applicant to avoid deficiencies that may have led to a delay in the approval of the ANDA.

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FY 2021 Pending Suitability Petitions under Section 505(j)(2) (C) of the FD&C Act*

  FY 2021
Petitions Pending a Substantive FDA Response *
Petitions Pending a Substantive FDA Response for More than 180 Days of Receipt *

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

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Previous Activities Reports

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