Marketing Status Notifications: FDA Drafts Guidance
Regulatory News | 30 January 2019 |
The US Food and Drug Administration (FDA) on Wednesday unveiled new draft guidance to help sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they’re now required to share with FDA on the marketing status of their brand and generic drugs.
Thanks to the FDA Reauthorization Act of 2017, drugmakers are required to provide additional information regarding the marketing status of approved drug products, including notification of a withdrawal from sale, notification of a drug not available for sale and a one-time report on marketing status for actively marketed drugs, which about 925 applicants already submitted.
“Having timely, accurate information about what drugs are being actively marketed helps provide transparency around circumstances where generic competition is lacking. It helps us also better understand circumstances where generic medicines are being approved, but not launched, so that we can better consider any policy reasons why this may be occurring,” FDA Commissioner Scott Gottlieb said.
The 5-page guidance identifies the required content for marketing status notifications, the recommended format for submitting these notifications to FDA and the required timelines for submission.
Orange Book Revamp
In addition to this draft guidance, FDA later this year plans to issue draft guidance describing how FDA evaluates therapeutic equivalence (TE) and assigns therapeutic equivalence codes, which are published in the Orange Book.
“We believe this guidance will increase transparency around the FDA’s policies and procedures related to evaluation and assignment of TE codes to support applicants submitting requests for therapeutic equivalence and help advance pathways for achieving pharmacy-level substitution of therapeutically equivalent drug products, including products approved under the 505(b)(2) pathway,” Gottlieb said.
He also said that this will be particularly beneficial for those seeking to develop more complex generic products that often face greater scientific and regulatory challenges, and which often have less competition.
Another draft guidance is also coming this year to assist applicants and approved application holders in using the Orange Book. Gottlieb said that the guidance will provide answers to commonly asked questions that FDA has received from interested parties.
“Separately, we’ll also be soliciting public comment on Orange Book use and potential enhancements, including a re-examination of what pharmaceutical patents should be listed in the Orange Book,” Gottlieb said.
For example, if a product has been approved for use in conjunction with a digital application, FDA said it may plan to consider whether the drug application holder should be required to list any patents associated with this digital application.
Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format: Draft Guidance for Industry
Thanks to the FDA Reauthorization Act of 2017, drugmakers are required to provide additional information regarding the marketing status of approved drug products, including notification of a withdrawal from sale, notification of a drug not available for sale and a one-time report on marketing status for actively marketed drugs, which about 925 applicants already submitted.
“Having timely, accurate information about what drugs are being actively marketed helps provide transparency around circumstances where generic competition is lacking. It helps us also better understand circumstances where generic medicines are being approved, but not launched, so that we can better consider any policy reasons why this may be occurring,” FDA Commissioner Scott Gottlieb said.
The 5-page guidance identifies the required content for marketing status notifications, the recommended format for submitting these notifications to FDA and the required timelines for submission.
Orange Book Revamp
In addition to this draft guidance, FDA later this year plans to issue draft guidance describing how FDA evaluates therapeutic equivalence (TE) and assigns therapeutic equivalence codes, which are published in the Orange Book.
“We believe this guidance will increase transparency around the FDA’s policies and procedures related to evaluation and assignment of TE codes to support applicants submitting requests for therapeutic equivalence and help advance pathways for achieving pharmacy-level substitution of therapeutically equivalent drug products, including products approved under the 505(b)(2) pathway,” Gottlieb said.
He also said that this will be particularly beneficial for those seeking to develop more complex generic products that often face greater scientific and regulatory challenges, and which often have less competition.
Another draft guidance is also coming this year to assist applicants and approved application holders in using the Orange Book. Gottlieb said that the guidance will provide answers to commonly asked questions that FDA has received from interested parties.
“Separately, we’ll also be soliciting public comment on Orange Book use and potential enhancements, including a re-examination of what pharmaceutical patents should be listed in the Orange Book,” Gottlieb said.
For example, if a product has been approved for use in conjunction with a digital application, FDA said it may plan to consider whether the drug application holder should be required to list any patents associated with this digital application.
Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format: Draft Guidance for Industry
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