December 6, 2024
No no, Novo!
APC responds to Novo’s nomination of semaglutide to DDC list
Novo Nordisk asked the FDA to put semaglutide on the Demonstrably Difficult to Compound (DDC) list, and now APC has formally responded, pulling exactly zero punches.
In a letter to the FDA, we pointed out the long list of problems Novo’s arguments, from the two and a half-year delay in the company’s request, to the fact that it deliberately tries to equate creating the semaglutide molecule with creating an injectable semaglutide compound.
We exposed the errors in Novo’s contention that its recombinant process is somehow superior to synthetic production of the injectable, as well as some “simply false” claims made by the company in its filing. And of course we pointed out the fact that there have been far more adverse-event reports from FDA-approved semaglutide products than from compounded versions.
Our conclusion:
Contrary to the contentions set forth in Novo Nordisk’s self-serving nomination letter, semaglutide injection is not demonstrably difficult to compound, it is not prepared from inferior API, and it should not be placed on the FDA’s DDC Lists.
Read the entire letter here. (Stat News even gave it a little coverage.)
