The US Food and Drug Administration (FDA) has issued a final guidance clarifying expectations for application holders required to submit marketing status notifications when their products are withdrawn from sale or are not available for sale.
Companies are required to notify FDA 180 days prior to when products marketed via new drug applications (NDA) and abbreviated new drug applications (ANDA) are withdrawn from the market. The guidance clarifies that it would be practicable for an application holder to notify FDA immediately after it decides to withdraw a product from sale.
The guidance further addresses questions regarding products marketed under multiple national drug codes (NDC). Withdrawal notifications should only be submitted when the product has been withdrawn under all relevant NDCs. The same expectation applies to NDA holders who have marketed a branded and generic version of the same drug.
Furthermore, the guidance notes that companies should provide an actual date to fulfil the withdrawal notification requirements, as well as the last date of manufacturing, distribution and LOT expiration dates if known.
In cases where an application holder has notified FDA that a product would not be available for sale but now intends to market the drug, the company should notify FDA 30-60 days before launch and not later than the date it begins marketing the product.
To view the guidance in full, click here.