D1S01-Kozak-v1.3-FINAL.pdf

1、Working Together to Increase Access to Generic DrugsOffice of Generic DrugsDr.Darby KozakGeneric Drugs ForumApril 9,2026Driving AccessState of the Generic Drug Program:Key Approval&Receipt MetricsNotable Generic Approvals andInitiativesApplicant and Public ResourcesLooking to the Futurewww.fda.govSt

2、ate of the Generic Drug Program:Generic Approvals Fiscal Year(FY)2025939 Abbreviated New Drug Applications(ANDAs)approved or tentatively approved,including:92 First generic ANDA approvals107 generic ANDAs with Competitive Generic Therapy designation125 Complex generic ANDAs3www.fda.govANDA Program:K

3、ey Actionswww.fda.govNotable FY 2025 Generic ApprovalsEstablished NameBrand NameIndicationApproval DateLiraglutide InjectionSaxendaChronic weight management August 2025Iron Sucrose InjectionVenoferIron deficiency anemia in CKD/dialysisAugust 2025Sitagliptin+Metformin XR Janumet XRType 2 diabetesJune

4、 2025Rivaroxaban XareltoAnticoagulation March 2025Siponimod MayzentMultiple sclerosis April 2025ANDA Program:Key Receiptswww.fda.govReduction in ANDA Refuse-to-Receive 7www.fda.gov8Improving Quality of ANDA Submissions:Resource Page for ANDA Applicantswww.fda.govhttps:/www.fda.gov/drugs/abbreviated-

5、new-drug-application-anda/helpful-webinars-and-other-resources-generic-drug-manufacturersIncreased Transparency for ANDAs with Missed Goal DatesWhen the Transparency Pilot is Utilized:The pilot is broadened from its initial focus on 60-day misses.It is specifically utilized when goal dates are likel

6、y to be missed due to a complicated issue that requires more in-depth communication.We aim to provide information on:By the goal date,applicants will be notified whether to anticipate an action on that date,such as an imminent action or a missed goal date.Which discipline(s)(e.g.,Bioequivalence,Qual