On February 5, 2018, FDA released a reminder that NDA and ANDA holders’ one-time reports on marketing status under the FDA Reauthorization Act of 2017 (FDARA) are due on February 14, 2018.

The reports must indicate whether each drug in the active section of the Orange Book (1) is available for sale, (2) has been withdrawn from sale, or (3) was never available for sale.

If all of an NDA or ANDA holder’s listed drugs are available for sale, the report should expressly state that the holder has reviewed the information published in the Orange Book and that all listed drugs are available for sale.

If one or more of an NDA or ANDA holder’s drugs has been withdrawn from sale, the report should identify each withdrawn drug’s National Drug Code; established name; proprietary name, if applicable; NDA or ANDA number; and strength; as well as the date on which it is expected to no longer be available or was no longer available for sale; and the reason(s) for the withdrawal.

If one or more of an NDA or ANDA holder’s drugs was never available for sale, the report should include each such drug’s established name; proprietary name, if applicable; NDA or ANDA number; and strength; as well as the date on which the drug will be available for sale, if known and applicable; and the reason(s) for not marketing the drug after approval.

The reporting requirements can be satisfied by submitting a letter to each applicable NDA or ANDA file through the electronic submissions gateway as part of a single grouped submission. FDA recommends that the submissions be identified as “MARKETING STATUS REPORT / ONE-TIME UPDATE.”