Regulatory Open Forum

I’m looking for some advice or confirmation that my thinking is correct, as this is an area that is new to me.

I’m looking at a product form of a drug (OTC NDA) that has been discontinued. The orange book shows the NDA as discontinued.  There is nothing stating that it was for safety reasons, I'm pretty certain that it was for marketing reasons (the same drug continues to be marketed in other dosage forms).  This NDA was not designated as an RLD.  If we wanted to market this dosage form I see two options. 

One would be to reactivate the discontinued NDA (possibly under a licensing agreement from NDA holder). For this option, is it simply requesting the NDA be reactivated and then submitting supplements for any changes from the original NDA?

The second option that I see would potentially to do an ANDA but since the original product was not an RLD, would it be possible to submit a suitability petition requesting to submit an ANDA to the RLD which is another dosage form and do bioequivalence to that form (which is what was originally done for the approval of the now discontinued NDA)? I feel like there may be a good chance of the suitability petition being approved since the dosage form we’re requesting already had existed.

How is an RLD determined?

Are there any options that I’m missing?

Thank you so much in advance for any information.

Dear Marcy,

You should factor market and fees into your submission plan, especially for an OTC product.

I agree with your second option, submit a suitability petition for the reference standard you selected.  You may have to submit a citizen petition under 21 CFR 10.25(a) and 10.30.

Another option is to submit a 505(b)(2) application.  However, ANDA cannot be cited as a listed drug in 505(b)(2) application, contemplates a 505(b)(2) applicant’s reliance on the Agency’s finding of safety and effectiveness that is contained in an NDA; and because an ANDA does not contain this finding, it cannot serve as a “listed drug for which FDA has made a finding of safety and effectiveness.” 

I have attached two useful guidance to this post.  Also, Orange Book Preface provides a short description about RLD/ RS.

I hope this helps.  Good Luck!

I’m looking for some advice or confirmation that my thinking is correct, as this is an area that is new to me.

I’m looking at a product form of a drug (OTC NDA) that has been discontinued. The orange book shows the NDA as discontinued.  There is nothing stating that it was for safety reasons, I'm pretty certain that it was for marketing reasons (the same drug continues to be marketed in other dosage forms).  This NDA was not designated as an RLD.  If we wanted to market this dosage form I see two options. 

One would be to reactivate the discontinued NDA (possibly under a licensing agreement from NDA holder). For this option, is it simply requesting the NDA be reactivated and then submitting supplements for any changes from the original NDA?

The second option that I see would potentially to do an ANDA but since the original product was not an RLD, would it be possible to submit a suitability petition requesting to submit an ANDA to the RLD which is another dosage form and do bioequivalence to that form (which is what was originally done for the approval of the now discontinued NDA)? I feel like there may be a good chance of the suitability petition being approved since the dosage form we’re requesting already had existed.

How is an RLD determined?

Are there any options that I’m missing?

Thank you so much in advance for any information.