常见ANDA重大缺陷分析-Kozak.pdf

1、Analysis of Common ANDA Major DeficienciesDarby Kozak,PhDDeputy Director Office of Generic Drugs|CDER|U.S.FDA10 April 20252025 Generic Drug ForumOutlineAnalysis of recent abbreviated new drug application(ANDA)submissions(FY18 to FY23),approval rates,and major deficiency trends based on size of gener

2、ic industry(number of approved ANDAs in company portfolio)and generic drug product complexity.Major bioequivalence(BE)deficiencies and detailed analysis of common BE deficiencies for topical dermatological product ANDAs.FDA initiatives and programs to address common issues and facilitate more first

3、and second cycle ANDA approvals.FY2018&FY2022 ANDA SubmissionsApproximately 38-40%of FY18 and FY22 ANDAs were approved by the second assessment cycle(applicant has received one complete response(CR)letter before approval).FDA and generic industry should strive to increase the percentage of ANDAs app

4、roved by second cycle.Assessment CycleComplex products accounted for 14%and 17%of ANDA submissions in FY18 and FY22,respectively.Approximately 25%of these complex product ANDAs were approved by the second cycle.ANDAs submitted in FY18 and FY22 provide sufficient time for at least two assessment cycl

5、es.Most FY18 ANDAs should be close to final action status(e.g.,approved or withdrawn/abandoned)where most FY22 ANDAs in CR will come back for third cycle.First Cycle Major DeficienciesApproximately 300 different companies submitted ANDAs in FY18&FY22.Very Large Company1(100 ANDAs),Large (20),Medium(

6、6),Small(6 ANDAs)Very large companies submitted half of all ANDAs.Complex product ANDAs make up 18%of ANDAs submitted by Very Large and Small companies.10%of ANDAs submitted by Large and Medium sized companies are for complex products.Manufacturing and Drug Product are most common major deficiencies