Depends. Assuming that the approved "reference listed drug" is
not an enteric coated (EC) product, you either can see if FDA will approve an ANDA suitability petition for the EC formulation or do the 505(b)(2). Of course, the user fees -- and potentially the development work as well -- associated with a 505(b)(2) NDA are significantly greater than going the ANDA route.
And, if the reference listed drug is an EC tablet, then you have to file it as an ANDA.
By the way, there is no bar on a tablet having different excipients from the approved drug. However, the PK profiles is a different issue. If an ANDA is possible (because the approved reference listed drug is EC), you will need to "match" PK profiles at least in the sense of proviing your product is bioequivalent to the RLD.
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Michael A. Swit, Esq.
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Original Message:
Sent: 06-11-2013 16:23
From: Meifang Liu
Subject: approval pathway for enteric-coated tablet?
Hi all, I am new here and I have a question. What is the appropriate pathway for an enteric-coated tablet that has the same API with the approved oral tablet? 505(b)(2) or ANDA?
My understanding would be 505(b)(2) as the enteric-coated will have different excipient and different PK profiles from the original one so that it is not ANDA, correct?
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Meifang Liu
Bridgewater NJ
United States
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