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Sermorelins FDA status Sermorelin was FDA-approved in 1997 as Geref, but its manufacturer (EMD Serono) voluntarily discontinued it and requested withdrawal of the new drug application in December 2008

Wu B, Lu NX, Xia YK, Gu AH, Lu CC, Wang W, et al

Regulatory note (June 2026): The FDA has proposed formally excluding semaglutide and tirzepatide from the 503B outsourcing facility bulk drug substances list

3 R -hydroxymyristate is a metabolic precursor for palmitic acid biosynthesis for incorporation into phospholipids, as well as for synthesis of lipid A