USA – Marketing status notifications: FDA fills in details in final guidance

The US Food and Drug Administration (FDA) on Monday finalized its guidance on marketing status notifications for new and generic drugs, clarifying its expectations for application holders required to submit marketing status notifications when their products are withdrawn from sale or are not available for sale.
 
Under the FDA Reauthorization Act of 2017 (FDARA), drugmakers are required to notify FDA regarding the marketing status of their approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) when those products are withdrawn or will not be available for sale.
 
The final guidance comes a year and a half after the agency issued the draft version for comment and no longer includes a section on the one-time updates required under FDARA, as the due date for the updates has passed and FDA says it has completed its review and updated the Orange Book accordingly. (RELATED: Marketing status notifications: FDA drafts guidanceRegulatory Focus 30 January 2019).
 
Final guidance
 
In the final guidance, FDA clarifies that it will use the information available to it, including annual reports, to determine whether a drug is unavailable and notes that, “A drug is considered withdrawn from sale when the application holder ceases its own distribution, even if the application holder eventually plans to return to the market,” except when due to a routine or temporary supply interruption…