Regulatory Open Forum

If you have an approved NDA for one indication and decide to withdraw it (not for safety/efficacy reasons), would any new indications of that drug be filed as a new NDA or an sNDA?

My interpretation is that since the original NDA no longer 'exists' it would make sense to submit the new indication as a new NDA, but I wanted to check with the community!

If an application is withdrawn and you want to file the drug product but for a new indication then yes a new application is required to the best of my knowledge.

If you have an approved NDA for one indication and decide to withdraw it (not for safety/efficacy reasons), would any new indications of that drug be filed as a new NDA or an sNDA?

My interpretation is that since the original NDA no longer 'exists' it would make sense to submit the new indication as a new NDA, but I wanted to check with the community!

On paper perhaps is more appropriate to say one needs a new NDA, however, logistically the new NDA must combine the data from the original NDA (as the basis) plus the data to support the sNDA indication! In other words, without the original approved NDA data, the sNDA will not be approved!

If an application is withdrawn and you want to file the drug product but for a new indication then yes a new application is required to the best of my knowledge.

If you have an approved NDA for one indication and decide to withdraw it (not for safety/efficacy reasons), would any new indications of that drug be filed as a new NDA or an sNDA?

My interpretation is that since the original NDA no longer 'exists' it would make sense to submit the new indication as a new NDA, but I wanted to check with the community!

If you have an approved NDA for one indication and decide to withdraw it (not for safety/efficacy reasons), would any new indications of that drug be filed as a new NDA or an sNDA?

My interpretation is that since the original NDA no longer 'exists' it would make sense to submit the new indication as a new NDA, but I wanted to check with the community!

It depends, I think, on how different the "new" application is from the old. If the only difference is the submission of new clinical data and new labeling, a supplemental application might make sense. Note that 21 CFR 314.150 states that "Withdrawal of approval of an application or abbreviated application ... is without prejudice to refiling". However, there are probably many reasons one could think of for filing a new NDA, but just a change in indication would not be one.

I would note that the withdrawn NDA does still exist and can still be incorporated into a new NDA by reference. Note the difference between a 505(b)(1) and 505(b)(2) here in that you still own the data from the original NDA, and that one can file a 505(b)(2) application and reference a withdrawn NDA if it was not withdrawn for safety reasons, 

If you have an approved NDA for one indication and decide to withdraw it (not for safety/efficacy reasons), would any new indications of that drug be filed as a new NDA or an sNDA?

My interpretation is that since the original NDA no longer 'exists' it would make sense to submit the new indication as a new NDA, but I wanted to check with the community!