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Sermorelin's FDA Journey: Approved, Discontinued, and Compounded Sermorelin acetate (Geref) was FDA-approved in 1997 for pediatric GHD 1 and in 1990 for diagnostic use.26 The manufacturer discontinued Geref in 2008 due to "manufacturing difficulties," not safety or efficacy concerns.12 In 2013, the FDA confirmed it wasn't withdrawn for safety/effectiveness, allowing for potential generic approvals.12 Currently, Sermorelin is primarily available as a compounded medication 3, which is permitted but not individually FDA-approved like mass-produced drugs.22 5.2

[ SOURCE: Reuters] As of June 2, 2025, the JPML reports there are 1,882 cases pending in the MDL -3094 IN RE: Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Products Liability Litigation