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  6. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description
  7. One-Time Report on Marketing Status Required by FDARA
  1. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description

One-Time Report on Marketing Status Required by FDARA

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 or 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 one or more of the NDA or ANDA holder’s drugs in the active section of the Orange Book have been withdrawn from sale or have never been available for sale.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 (i.e., by Wednesday, February 14, 2018). Here is information on how NDA and ANDA holders can submit this information to FDA:

  • 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. Please prominently identify the submission as “MARKETING STATUS REPORT / ONE-TIME UPDATE.”
  • In the letter, indicate whether:
    • all of the NDA or ANDA holder’s drugs in the active section of the Orange Book are available for sale; or
    • one or more of the NDA or ANDA holder’s drugs in the active section of the Orange Book have been withdrawn from sale or have never been available for sale.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, 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. As noted above, please submit the one-time report to each NDA or ANDA file covering drug products listed in the active section of the Orange Book.
  • If one or more of the NDA or ANDA holder’s drug products listed in the active section of the Orange Book have been withdrawn from sale or have never been available for sale, the report should include the following:
    • For drug products that have been withdrawn from sale, 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 drug products that have never been available for sale, include:
      • 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 will be available for sale, if known and applicable; and
      • Reason(s) for not marketing the drug after approval.
    • For the NDA or ANDA holder’s other drug products listed in the active section of the Orange Book that are available for sale, 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 other drug products in the active section of the Orange Book are available for sale. As noted above, please submit the one-time report to each applicable NDA or ANDA file through the electronic submissions gateway as part of a single grouped submission, including to each NDA or ANDA file covering drug products listed in the active section of the Orange Book that are available for sale.

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Frequently Asked Questions

Q1. Does a report get submitted to each NDA or ANDA?
A1. Yes, please submit a report to each applicable NDA and ANDA. NDA and ANDA holders can create a single report providing the required information, and submit an identical copy of this report to each of the NDAs or ANDAs covered by the report.

Q2. Should a separate cover letter be included with the one-time report?
A2. No. The report can serve as its own cover letter; no separate cover letter is necessary.

Q3. Do NDA or ANDA holders have to review their products in the discontinued section of the Orange Book for the one-time report?
A3. No; the one-time report is based on a review of the NDA or ANDA holders’ information in the active section of the Orange Book.

Q4. What version of the Orange Book should NDA or ANDA holders use to prepare their one-time report?
A4. Please review the information in the most current version of the Orange Book, www.fda.gov/orangebook, to prepare your one-time report. In the report, please address all of your drugs in the active section of the Orange Book at the time the one-time report is prepared, including any drugs approved after FDARA was enacted.

Q5. Does a Form 356h get included with the one-time report?
A5. Yes, please include a new Form FDA 356h per the Form FDA 356h instructions with each submission of the one-time report to an NDA or ANDA file.

Q6. Can an NDA or ANDA holder submit the one-time report as a grouped submission?
A6. An NDA or ANDA holder can submit the report as a grouped submission if the holder is using the new module 1 (v3.3 DTD) for eCTD. If the holder has the new module 1 (v3.3 DTD) for eCTD, the holder can submit one Form 356h for a grouped submission. Otherwise, NDA and ANDA holders can submit copies of their one-time report to each of the NDAs or ANDAs covered by the report individually as described above (one submission per application).

For questions related to electronic Common Technical Document submissions (e.g., submission type, grouping of submissions), please see www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm or contact the CDER Electronic Submission (ESUB) Support Team at esub@fda.hhs.gov.

If you have additional questions regarding the information described above, please send them to the Orange Book staff at orangebook@fda.hhs.gov.

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