Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format

This guidance is intended to assist holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) approved under section 505(c) and 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(c) and (j)), respectively, with submission of marketing status notifications required under section 506I of the FD&C Act (21 U.S.C. 356i). This guidance identifies the required content for these marketing status notifications and the format by which these notifications should be submitted to the Agency.

FDA regulations require NDA and ANDA holders to notify the Agency of the marketing status of drug products approved under NDAs and ANDAs. The FDA Reauthorization Act of 2017 (FDARA) added section 506I to the FD&C Act, which imposes additional marketing status reporting requirements as follows:

• Notification of withdrawal from sale — requires NDA and ANDA holders to provide a written notification to FDA 180 days prior to withdrawing an approved drug from sale.
• Notification of drug not available for sale — requires NDA and ANDA holders to provide a written notification to FDA within 180 days of the date of approval of a drug if that drug will not be available for sale within 180 days of the date of approval.
• One-time report on marketing status — requires NDA and ANDA holders to provide a written notification to FDA within 180 days of enactment of FDARA stating whether the NDA and ANDA holder’s drug(s) in the active section of the Orange Book were available for sale or if one or more of the NDA or ANDA holder’s drugs in the active section had been withdrawn from sale or had never been available for sale.