“Repeat-dose toxicology studies were conducted in rats and dogs for up to 28 days.”
✓ VerifiedFDA multi-discipline review, p. 56Source ↗
Pivotal GLP studies
28-day oral studies in rats and dogs
“The liver and thymus were identified as the target organs of toxicity in repeat-dose toxicity studies in rats and dogs at doses of 50, 200, and 800 mg/kg/day for 28 days.”
✓ VerifiedFDA multi-discipline review, p. 57Source ↗