Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We have a generic drug product that has been discontinued in 2019 (last U.S. sales date). I am trying to confirm if we are still required by the FDA to submit Annual Reports for this discontinued drug. If we are, for how long and what are the required sections to be submitted in the Annual Report? 

Thank you!

I have to start with its been a few years since I focused on ANDA products so I am not sure how much has changed. When I did focus on ANDA products I was with an organization that had about 20 generic products with a half dozen or so no longer commercialized. So my knowledge given that perspecitve: so long as the ANDA is active (i.e. not withdrawn) you are still required to submit an annual report. To be safe I would include every section that you would in a normal report and just explain the product is no longer commercialized. You should alo continue to complete PADER's or adverse event reporting. Bacially so long as this ANDA is active you are required to report as normal. FDA does not have a special category for an inactive drug. Think of it this way, you're keeping the ANDA with FDA, so nothing is stopping you from re-launching the product tomorrow.

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Marcella Martin RAC, MBA
Senior Regulatory Consultant
Fort Collins CO
United States
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Original Message:
Sent: 02-Feb-2023 12:13
From: Anonymous Member
Subject: Annual Reports for Discontinued Drug Product

This message was posted by a user wishing to remain anonymous

We have a generic drug product that has been discontinued in 2019 (last U.S. sales date). I am trying to confirm if we are still required by the FDA to submit Annual Reports for this discontinued drug. If we are, for how long and what are the required sections to be submitted in the Annual Report?

Thank you!

Hi,
I agree with Marcella.  As long as the ANDA hasn't been withdrawn, you are required to submit Annual Reports and PADERs.  You would report no changes and no distribution.  Keep in mind that sometimes a change to a common excipient or packaging component in a different product can affect your discontinued products also.

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Lisa Apolis, RAC
Apolis Regulatory Consulting
Georgia, USA
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Original Message:
Sent: 03-Feb-2023 12:34
From: Marcella Martin
Subject: Annual Reports for Discontinued Drug Product

I have to start with its been a few years since I focused on ANDA products so I am not sure how much has changed. When I did focus on ANDA products I was with an organization that had about 20 generic products with a half dozen or so no longer commercialized. So my knowledge given that perspecitve: so long as the ANDA is active (i.e. not withdrawn) you are still required to submit an annual report. To be safe I would include every section that you would in a normal report and just explain the product is no longer commercialized. You should alo continue to complete PADER's or adverse event reporting. Bacially so long as this ANDA is active you are required to report as normal. FDA does not have a special category for an inactive drug. Think of it this way, you're keeping the ANDA with FDA, so nothing is stopping you from re-launching the product tomorrow.

------------------------------
Marcella Martin RAC, MBA
Senior Regulatory Consultant
Fort Collins CO
United States

Original Message:
Sent: 02-Feb-2023 12:13
From: Anonymous Member
Subject: Annual Reports for Discontinued Drug Product

This message was posted by a user wishing to remain anonymous

We have a generic drug product that has been discontinued in 2019 (last U.S. sales date). I am trying to confirm if we are still required by the FDA to submit Annual Reports for this discontinued drug. If we are, for how long and what are the required sections to be submitted in the Annual Report?

Thank you!