Cholesterol Management Supplement Found to Contain Undeclared Rx Ingredient
Cholestene, a dietary supplement marketed for cholesterol management, has been found to contain a hidden drug ingredient, according to the Food and Drug Administration.
Cholestene, a dietary supplement marketed for cholesterol management, has been found to contain a hidden drug ingredient, according to the Food and Drug Administration.
Wegovy contains semaglutide, a GLP-1 receptor agonist.
Teplizumab is an investigational anti-CD3 monoclonal antibody.
The claims made on these websites establish these products as drugs under the Federal Food, Drug, and Cosmetic Act; however, none were evaluated by the FDA.
The 52-week SURPASS-4 trial is part of a phase 3 global clinical development program for tirzepatide, a novel, once-weekly, dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist.
The approval was based on data from the DAPA-CKD trial, which compared dapagliflozin, an SGLT2 inhibitor, to placebo on renal outcomes and cardiovascular mortality in patients with CKD.
Findings of the review showed that continuous insulin infusion, coupled with standard oral lipid lowering therapies, successfully treated the hypertriglyceridemia.
The double-blind, placebo-controlled phase 3 study included 229 women who completed the LIBERTY long-term extension study.
The fact sheets for bamlanivimab, bamlanivimab and etesevimab, and REGEN-COV (casirivimab and imdevimab) have been updated.
Inclisiran is a chemically synthesized small interfering RNA that targets proprotein convertase subtilisin-kexin type 9 (PCSK9) messenger RNA.