Approved new drug application (NDA) and abbreviated new drug application (ANDA) holders must act quickly to remain in accordance with Section 506I(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In compliance with Section 506I(c) of the FD&C Act, the information published in the FDA publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book), must be reviewed and confirmed by a sponsor and reported to the FDA no later than Wednesday, February 14, 2018. The “one-time” marketing status report must indicate that (i) all of the application holder’s drugs in the active section of the Orange Book are available for sale or (ii) one or more of the application holder’s drugs in the active section of the Orange Book have been withdrawn for sale or have never been available.
Background on FDARA
February 18, 2018 marks 180 days since the enactment of Section 804 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA), which amended the FD&C Act with section 506I, entitled “Propmt reports of Marketing Status.” Subsection 506I(c) set the 180-day deadline. Failure to submit the one-time marketing status report could result in FDA moving an NDA or ANDA holder’s approved drug(s) from the active section of the Orange Book to the discontinued section.
FDA marketing status reporting procedures
Specific procedures for submitting the required one-time report can be found on this FDA webpage: One-Time Report on Marketing Status by FDARA.