FDA requires one-time marketing status reports by February 2018

The US Food and Drug Administration (FDA) has requested that all new drug application (NDA) and abbreviated new drug application (ANDA) holders to submit one-time written reports on whether their products are available for sale or if they have been withdrawn or were never made available for sale. This one-time marketing status report needs to be submitted to the FDA by 14th February 2018.

The FDA states that “the NDA or ANDA holder can submit the one-time report to FDA by letter to each applicable NDA or ANDA file (i.e., each NDA or ANDA listed in the active section of the Orange Book that is covered by such one-time report) through the electronic submissions gateway as part of a single grouped submission. In other words, the same report could be submitted to each applicable NDA and ANDA file as part of a single grouped submission”.

The letter should indicate whether:

  1. all of the NDA or ANDA holder’s drugs 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 one or more of the NDA or ANDA holder’s drugs in the active section of the Orange Book have been withdrawn from sale or have never been available for sale.

If all of the NDA or ANDA holder’s drugs in the active section of the Orange Book are available for sale, the FDA states “please include a statement in the one-time report confirming that you have reviewed the information published in the Orange Book and that all of your drug products in the active section of the Orange Book are available for sale”.

Drug products that have been withdrawn from sale should include: National Drug Code; Established name of the drug; Proprietary name of the drug, if applicable; NDA or ANDA number for the drug; Strength of the drug; Date on which the drug is expected to no longer be available, or was no longer available for sale; and reason(s) for the withdrawal from sale of the drug.

For drugs that have never been available for sale, FDA said to include all the above except for the national drug code and include the reason for not marketing the drug.

For more information regarding the one-time report on marketing status, please click here.