Growing Numbers of Priority and Competitive ANDAs Under Review as Approvals Trickle In

Regulatory NewsRegulatory News
| 15 August 2019 | By Michael Mezher 

The US Food and Drug Administration (FDA) on Wednesday released quarterly data on two of its programs aimed at increasing generic competition and speeding the approval of priority generic drugs.
The FDA Reauthorization Act of 2017 (FDARA) included provisions to shorten the reviews of certain abbreviated new drug applications (ANDAs) by two months under a new priority review program as well as a new competitive generic therapy (CGT) designation intended to increase competition for drugs with only one generic competitor on the market.
While priority ANDAs are granted shorter review times, FDA explained in draft guidance earlier this year that while it may take actions to expedite the review of certain CGTs, “an expedited review does not result in a shorter [Generic Drug User Fee Amendments] GDUFA goal date.” The guidance also explains steps FDA may take to expedite the development and review of CGTs, which include product development meetings, pre-submission meetings and mid-review cycle meetings.
FDA says it will consider issues such as the complexity of the product being developed, the potential public health impact and impact on FDA’s workload when considering granting product development meetings and pre-submission meetings.
FDARA also requires FDA to report on its activities related both priority generics and ANDAs with competitive generic therapy designation.
Data through Q3 FY2019, combined with quarterly data from FY2018, shows that while the number of ANDAs awaiting action by either FDA or their sponsors have steadily ticked up since FDARA went into effect, by the end of the third quarter priority ANDAs awaiting FDA action leveled off.
  FY2018 FY2019
  Q1 Q2 Q3 Q4 Q1 Q2 Q3
Priority ANDAs Awaiting FDA Action 2 6 16 29 27 52 48
Priority ANDAs Awaiting Applicant Action 0 0 0 3 9 10 17
CGTs Awaiting FDA Action 3 16 33 45 48 57 84
CGTs Awaiting Applicant Action 0 0 0 2 17 26 25
In FY2018, FDA did not approve any priority ANDAs, though this is not surprising as only a handful of priority applications were awaiting action by the end of the first quarter that year. In the fourth quarter of FY2018, the agency approved its first three ANDAs with CGT designation.
In FY2019, FDA approved three priority ANDAs in each of the first and second quarters, and four in the third quarter. So far this year, FDA has approved eight ANDAs with CGT designation.
Across both FY2018 and FY2019, few applicants with CGT designation have requested pre-submission or product development meetings.
  FY2018 FY2019
  Q1 Q2 Q3 Q4 Q1 Q2 Q3
Pre-submission Meetings Requested 1 0 0 1 0 1 1
Pre-submission Meetings Held 0 0 0 0 0 2 0
Product Development Meetings Requested 2 1 2 1 4 0 3
Product Development Meetings Held 0 0 0 1 2 1 4
Quarterly Data FY2018, FY2019


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