The US Food and Drug Administration (FDA) on Wednesday unveiled new draft guidance to help sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they’re now required to share with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In addition to this draft guidance, FDA later this year plans to issue draft guidance describing how FDA evaluates therapeutic equivalence (TE) and assigns therapeutic equivalence codes, which are published in the Orange Book…