Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We have a FDA-approved generic drug product and would like to reformulate it to add new excipients (all used in previously FDA-approved drug products), which would allow us to reduce one of the side effects associated with the product. We would also like to add a modifier to the proprietary name to differentiate the new product and highlight the new formulation benefit. Can this change be approved under a supplement to the original ANDA? Any advice on what type of information may be required by the FDA?

"which would allow us to reduce one of the side effects associated with the product" "would also like to add a modifier to the proprietary name to differentiate the new product and highlight the new formulation benefit."

To support the above statements one would require a clinical efficacy study and cannot be filed as a supplement to the ANDA or a new ANDA. Without all the details, I would say it belongs to 505(b)(2) NDA.

Contact me privately if you need help!




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GRSAOnline
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Original Message:
Sent: 08-Nov-2022 09:32
From: Anonymous Member
Subject: New Formulation Approval for Generic Drug Product

This message was posted by a user wishing to remain anonymous

We have a FDA-approved generic drug product and would like to reformulate it to add new excipients (all used in previously FDA-approved drug products), which would allow us to reduce one of the side effects associated with the product. We would also like to add a modifier to the proprietary name to differentiate the new product and highlight the new formulation benefit. Can this change be approved under a supplement to the original ANDA? Any advice on what type of information may be required by the FDA?

That's a 505(b)(2) not an ANDA.

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Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States
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Original Message:
Sent: 08-Nov-2022 09:32
From: Anonymous Member
Subject: New Formulation Approval for Generic Drug Product

This message was posted by a user wishing to remain anonymous

We have a FDA-approved generic drug product and would like to reformulate it to add new excipients (all used in previously FDA-approved drug products), which would allow us to reduce one of the side effects associated with the product. We would also like to add a modifier to the proprietary name to differentiate the new product and highlight the new formulation benefit. Can this change be approved under a supplement to the original ANDA? Any advice on what type of information may be required by the FDA?