United States Reissued Patent USRE42645 (E) Drakulic T, Temple MD, Guido R, Jarolim S, Breitenbach M, Attfield PV, Dawes IW (2005) Involvement of oxidative stress response genes in redox homeostasis, the level of reactive oxygen species, and ageing in Saccharomyces cerevisiae
However, no FDA rule has changed
Current Opinion in Investigational Drugs, 7(4), 312-318
Lysates from cells cultured in HD medium for 72 h served as negative controls
Both are within the 28-day stability window
It is available only by prescription, and outside that approved indication it is prescribed off-label and often dispensed as a compounded preparation through 503A/503B compounding pharmacies for bodybuilding, fat-loss, or anti-aging purposes, uses the FDA has not evaluated or approved