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What is an Approved DESI Product?

I am hesitant to contribute more information about so-called DESI drugs at the risk of further confusion.  My goal is always to provide clarity, so here goes.

Fundamental to any discussion about DESI products is the definition of a drug product.  Let’s just focus on one part of the definition – the labeling.  A drug product includes the labeling.  Labeling includes the language on the package and any language on the package inserts.

So a drug that was reviewed under the DESI program, where the notice indicates that the drug product may be administered to children over 2 years old with X mL per given time period can safely be marketed, but a drug product with labeling stating that the drug may be administered to children over 3 months old, may not be marketed without FDA approval via an NDA the two products may contain the very same ingredients, but they are different because the labeling is different.

If a manufacturer makes a product that contains the same ingredients and the same labeling as stated in the DESI notice, then it can be marketed.  Otherwise, an NDA, filed under 505(b)(2), will be needed to prevent seizure by the FDA.