"However that co-former is currently listed in the IIG database but we would like to use it (co-former) at a higher level. Has anyone dealt with a similar situation, if so what was your approach/strategy?"
Since you are proposing to use the co-former at a higher level than what is permitted in the FDA's IIG database, I would lean more towards a 505(b)(2) NDA strategy rather than an ANDA from the regulatory standpoint. Please share the FDA feedback once you receive it.
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GRSAOnline
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Original Message:
Sent: 10-Jul-2017 17:33
From: Sabrina Dessources
Subject: Co-former/Co-crystal
Hello everyone,
I am wondering if anyone has any co-former experience/knowledge that they would be willing to share? The company is planning to develop an API (for a generic submission) using an ingredient as a co-former to form the drug-co crystal. We already know that the co-former dissociates from the API before reaching the site of pharmacological activity, therefore it's not a "new" API. However that co-former is currently listed in the IIG database but we would like to use it (co-former) at a higher level. Has anyone dealt with a similar situation, if so what was your approach/strategy?
I sent a controlled correspondence to the FDA asking for their input on increasing the level of that ingredient, but wanted to hear from other people's experience as well.
Thanks,
Sabrina