Generic Drugs Program Fiscal Year 2025 Activities Report

Original ANDA ReviewStandard Original ANDA Submissions10 months29 of 40097%7% to 99%100%7% to 100%Priority Original ANDA Submissions (if applicant meets requirements of a PFC)8 months5 of 18100%28% to 100%100%28% to 100%Priority Original ANDA Submissions (if applicant does not meet the requirements of a PFC)10 months5 of 66100%8% to 100%100%8% to 100%Standard and Priority Original Facility not Ready with Reset30 months----------Amendment ReviewStandard Major ANDA Amendments (if PAI is not required)8 months167 of 51395%31% to 98%98%32% to 99%Standard Major ANDA Amendments (if PAI is required)10 months2 of 8100%25% to 100%100%25% to 100%Priority Major ANDA Amendments (if PAI is not required)6 months41 of 88100%47% to 100%100%47% to 100%Priority Major ANDA Amendments (if PAI is required and applicant meets the requirements of a PFC)8 months----------Priority Major ANDA Amendments (if PAI is required and applicant does not meet the requirements of a PFC)10 months----------Standard and Priority Minor ANDA Amendments3 months485 of 74686%58% to 91%98%64% to 99%PAS Review Time GoalsStandard PAS (if PAI is not required)6 months973 of 168599%57% to 99%99%58% to 99%Standard PAS (if PAI is required)10 months6 of 25100%24% to 100%100%24% to 100%Priority PAS (if PAI is not required)4 months89 of 11896%74% to 97%99%75% to 99%Priority PAS (if PAI is required and applicant meets the requirements of a PFC)8 months0 of 1--------Priority PAS (if PAI is required and applicant does not meet the requirements of a PFC)10 months1 of 3100%33% to 100%100%33% to 100%PAS Amendment Review Time GoalsStandard Major PAS Amendment (if PAI is not required)6 months51 of 102100%50% to 100%100%50% to 100%Standard Major PAS Amendment (if PAI is required)10 months0 of 1--------Priority Major PAS Amendment (if PAI is not required)4 months8 of 1188%64% to 91%100%73% to 100%Priority Major PAS Amendment (if PAI is required and applicant does not meet the requirements of a PFC)10 months----------