FDA shows jump in competitive generic approvals

Regulatory NewsRegulatory News
| 20 October 2021 | By Joanne S. Eglovitch 

The US Food and Drug Administration (FDA) approved a steadily increasing number of competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) in FY 2021 while the number of priority generic approvals leveled off, according to agency’s quarterly data on reviews and approvals of priority and competitive generics.
 
FDA approved 29 priority ANDAs in FY 2021, one more than the 28 approved in  FY 2020. There was an increase of about 8% in the number of priority ANDAs awaiting agency action, from 210 in FY 2020 to 227 in FY 2021. 
 
The number of competitive generics approved by FDA increased from 35 in FY 2020 to 53 in FY 2021, while the number of CGTs awaiting agency action jumped from 390 in FY 2020 to 521 in FY 2021.
 
The FDA Reauthorization Act of 2017 (FDARA), which reauthorized the Generic Drug User Fee Act (GDUFA) for five years, requires FDA to report on ANDAs subject to priority review and certain ANDAs with a competitive generic therapy designation.
 
The tables show 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 in each of these categories during the reporting quarter.
 
ANDAs subject to priority review
FY 2020   FY 2021  
  Q1 Q2 Q3 Q4 Total Q1 Q2 Q3 Q4 Total
ANDAs awaiting FDA action 55 51 56 48 210 54 58 59 56 227
ANDAs awaiting applicant action 16 22 20 27 85 18 19 25 31 93
ANDAs approved 11 3 7 7 28 6 10 4 9 29
 
 
ANDAs with a Competitive Generic Therapy Designation
FY 2020   FY 2021  
  Q1 Q2 Q3 Q4 Total Q1 Q2 Q3 Q4 Total
ANDAs awaiting FDA action  72 83 108 127 390 114 129 132 146 521
ANDAs awaiting applicant action 45 51 44 43 183 53 55 76 75 259
ANDAs approved 11 4 10 10 35 14 15 10 14 53
Presubmission meetings requested 1 0 0 0 1 0 0 0 1 1
Product development meetings requested 3 2 12 8 25 4 4 6 7 21
Product development meetings held 3 2 4 6 15 7 5 5 7 24
 
FDA activities report for FY 2021
 
FDA activities report for FY 2020
 
 
 

 

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