As per the FDA Reauthorization Act (FDARA) of 2017, drug marketing holders are responsible to notify the FDA about the status of the NDA or ANDA product withdrawal. The United States Food and Drug Administration clarifies its expectation by updating the final guidance for the application holders to submit marketing notification withdrawal.

Guidance updates:

The final guidance updates are as follows:

  1. Notification of withdrawal from sale – this requires the application holders to submit a notification to the FDA of withdrawing the product 180 days prior withdrawing the drug product.
  2. Notification of drug not available for sale – under this notification, ANDA/NDA holder needs to provide FDA a written notification within 180 days of date drug that will be unavailable for sale.
  3. One-time report on marketing status – this is required for NDA and ANDA holders to notify the FDA within 180 days stating the status of the drug in the Orange book is available for sale or the active section has been withdrawn.

The Withdrawal Application:

The withdrawal application should include:

  1. The National Drug Code(s) (NDCs) under which the drug is listed, if applicable
  2. The established name of the drug
  3. The proprietary name of the drug, if applicable
  4. The NDA or ANDA number
  5. The strength of the drug
  6. The date on which the drug is expected to no longer be available for sale
  7. The reason for the withdrawal

FDA will consider the drug withdrawn, once the sale/distribution of the drug is ceased by the manufacturer even if the application holder plans to return the drug to the market.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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