“Twenty-eight-day repeat dose oral administration toxicity studies were conducted in dogs with initial ferric maltol doses of 0, 250, 500, and 1000 mg/kg.”
✓ VerifiedFDA multi-discipline review, p. 27Source ↗
Pivotal GLP studies
GLP 28-day oral (gavage then capsule) dog study with ferric maltol
“Study title/ number: Iron Maltol: 28 Day Oral (Gavage/Capsule) Sub-Chronic Toxicity Study in the Beagle/6148-148/40”
✓ VerifiedFDA multi-discipline review, p. 29Source ↗
Route in tox
Oral (gavage days 1–5, then capsule)
“Route of administration: Oral gavage on days 1 through 5 then oral capsule from day 6 onward.”
✓ VerifiedFDA multi-discipline review, p. 30Source ↗