Its a formulation change (I understand it is significant since you are conducting a pk study to support it), not a dosage form change, so I'd bet on supplement not a new NDA with the original approved NDA still active! However, with dosing regimen change (need more details, not sure how significant), once it is approved you could consider withdrawing the original NDA.
------------------------------
GRSAOnline
------------------------------
Original Message:
Sent: 21-Apr-2023 08:00
From: Sudhir Kaushal
Subject: New NDA under 505 b (2) pathway or a supplement to NDA
Thanks Narayan for your quick response! The change is formulation is to improve the safety of the product. So if the sponsor wants to submit it as a new NDA instead of a supplement, I was wondering if FDA will have any restrictions on submitting it as an NDA instead of a supplement (I will appreciate if you have any reference for the same). The change in the formulation will also require a PK study as the change in the formulation will be significant.
Also if the variation also involves a change in the dosing regimen along with formulation change, Does that qualify for a new NDA or it can still be a supplement?
Thank you!
------------------------------
Sudhir Kaushal RAC
Sr. Director
Mahwah NJ
United States
Original Message:
Sent: 20-Apr-2023 21:44
From: Narayan Rao
Subject: New NDA under 505 b (2) pathway or a supplement to NDA
If the original NDA is owned by ABC and the same NDA holder wish to submit a new formulation (NOT a new dosage form) of the original approved NDA, it should be supplement!
------------------------------
GRSAOnline
Original Message:
Sent: 20-Apr-2023 15:10
From: Anonymous Member
Subject: New NDA under 505 b (2) pathway or a supplement to NDA
This message was posted by a user wishing to remain anonymous
If there is an approved NDA held by an ABC company with US FDA, Can they file a new NDA under 505b(2) route for a totally different formulation to reduce the safety-related issues because of the excipient in the first NDA? The dosage form, route of administration, and indication is remaining the same. Or FDA will push for a supplement for this type of variation. I will appreciate any thoughts in this type of situation. If there is any reference to support your thoughts would be great. <o:p></o:p>