Regulatory Open Forum

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​​Can sNDA be submitted for a change in dosing for an approved indication with a separate label and a new proprietary name? (i.e. formulation, indication, etc. remain the same).

Thanks!

This message was posted by a user wishing to remain anonymous

Is the dosage form different from the original NDA? i.e. if the original NDA is tablets, the new proposed submission with new proprietary name being capsules or MR etc.

If the dosage form is different, then a new NDA is expected with cross reference to the original NDA for rest of the information that is already approved.
Original Message:
Sent: 03-Aug-2018 15:18
From: Anonymous Member
Subject: NDA Supplement - different proprietary name and label

This message was posted by a user wishing to remain anonymous

​​Can sNDA be submitted for a change in dosing for an approved indication with a separate label and a new proprietary name? (i.e. formulation, indication, etc. remain the same).

Thanks!

A supplement to an NDA can be filed for a different drug product ("a drug is a different drug if it has been modified to have a different active ingredient, different route of administration, different dosage form, or difference in excipients that requires ... a separate clinical study to establish safety or effectiveness").  Generally though, as I  understand it, you would not be able to have a different label - if by that you mean "package insert" for a product that has the same active ingredient for the same indication.  If you want a new name and new label with unique dosing instructions, I think you would need agreement from FDA on how to submit - maybe a 505(b)(2)?

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Glen Park
Jersey City NJ
United States
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Original Message:
Sent: 03-Aug-2018 15:18
From: Anonymous Member
Subject: NDA Supplement - different proprietary name and label

This message was posted by a user wishing to remain anonymous

​​Can sNDA be submitted for a change in dosing for an approved indication with a separate label and a new proprietary name? (i.e. formulation, indication, etc. remain the same).

Thanks!

This message was posted by a user wishing to remain anonymous

"A supplement to an NDA can be filed for a different drug product ("a drug is a different drug if it has been modified to have a different active ingredient......."

I don't think that an sNDA can be filed if it has a different active ingredient from the original approved NDA. 
Original Message:
Sent: 09-Aug-2018 08:34
From: Glen Park
Subject: NDA Supplement - different proprietary name and label

A supplement to an NDA can be filed for a different drug product ("a drug is a different drug if it has been modified to have a different active ingredient, different route of administration, different dosage form, or difference in excipients that requires ... a separate clinical study to establish safety or effectiveness").  Generally though, as I  understand it, you would not be able to have a different label - if by that you mean "package insert" for a product that has the same active ingredient for the same indication.  If you want a new name and new label with unique dosing instructions, I think you would need agreement from FDA on how to submit - maybe a 505(b)(2)?

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Glen Park
Jersey City NJ
United States

Original Message:
Sent: 03-Aug-2018 15:18
From: Anonymous Member
Subject: NDA Supplement - different proprietary name and label

This message was posted by a user wishing to remain anonymous

​​Can sNDA be submitted for a change in dosing for an approved indication with a separate label and a new proprietary name? (i.e. formulation, indication, etc. remain the same).

Thanks!

Hello,

It's unclear from the question if you're creating a new product with a new name and new dosing that will be marketed alongside an existing product or if you're simple changing an existing product's proprietary name and dosing and updating the labeling accordingly. It seems that the first option would necessitate a new NDA submission (maybe 505(b)(2) as someone suggested) and the second option would be a major change to an existing NDA, requiring a PAS with both labeling and proprietary name reviews.

Good luck!
Courtney

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Courtney Portik
Atlanta GA
United States
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Original Message:
Sent: 03-Aug-2018 15:18
From: Anonymous Member
Subject: NDA Supplement - different proprietary name and label

This message was posted by a user wishing to remain anonymous

​​Can sNDA be submitted for a change in dosing for an approved indication with a separate label and a new proprietary name? (i.e. formulation, indication, etc. remain the same).

Thanks!