ESPL Regulatory Consulting

News

Regulatory News and Updates

FDA mandates a review of the Orange Book by ANDA and NDA holders no later than February 14, 2018

Attention ANDA and NDA holders: One-time report on market status for all approved drug products due February 14, 2018

The FDA Reauthorization Act of 2017 (FDARA), enacted on August 18, 2017, added section 506I to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 506I imposes certain reporting requirements on new drug application (NDA) and abbreviated new drug application (ANDA) holders regarding the marketing status of approved products, including a one-time marketing status report.

Under section 506I(c) of the FD&C Act, all NDA and ANDA holders are to review information published in FDA’s publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book), and submit a one-time written report to FDA indicating that:

  1. the NDA and ANDA holder’s drug(s) in the active section of the Orange Book are available for sale; or
  2. one or more of the NDA or ANDA holder’s drugs in the active section of the Orange Book have been withdrawn from sale or have never been available for sale.

Section 506I(c) of the FD&C Act requires that this one-time marketing status report be submitted to the FDA within 180 days of enactment of FDARA. As a result, this one-time marketing status report is due to the FDA on Wednesday, February 14, 2018. The agency has published information on the FDA website regarding how NDA and ANDA holders can submit the one-time marketing status report to FDA.

MedicinesChris ErwoodFDA