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Hello,
We are exploring an auto generic/ or second brand option for one of our marketed products and I was wondering if anyone had any experience with 'authorized generics' and next steps from a regulatory perspective. The FDA website (link provided below) just mentions that the NDA holder has to notify the FDA if it markets an authorized generic.
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm126389.htmIs there anything else from a brand name perspective or labeling perspective that we as the sponsor are required to do before we market an authorized generic?
Any feedback or guidance would be much appreciated!