OBJECTIVES: The study was conducted to provide a comparative analysis of pituitary and hypothalamic hormones and analogues approved by the US Food and Drug Administration (FDA) and Health Canada (HC). METHODS: The World Health Organization (WHO), FDA, and HC websites were used to obtain the data of pituitary and hypothalamic hormones and analogues, approval dates, indications, contraindications, market status, dosage forms, strengths, and routes of administration. Descriptive statistics and Wilcoxon Signed rank test were performed. RESULTS: Twenty eight drugs were identified, of which 15 were approved by the FDA and 16 were approved by HC. Among the 13 drugs marketed in both the US and Canada, two drugs were excluded due to missing information. Of the 11 remaining drugs, 8 drugs (72.7%) were approved by the FDA first, while 3 drugs (27.3%) were approved by HC first. The average (±SD) number of approved indications by the FDA (1.82±0.98) was not significantly different from that approved by HC (2.45±1.75) (P-value=0.25). HC approved more indications than the FDA for 3 drugs (Somatropin, Tesamorelin, and Octreotide), and each agency approved different indications in one drug (Nafarelin). HC’s average number (±SD) of contraindications (4.27±2.65) was significantly different from that of the FDA’s (2.36±2.06) (P-value=0.003). CONCLUSIONS: There were differences in the number of pituitary and hypothalamic hormones and analogues approved by both agencies. Different indications and contraindications were also found for the same drugs comparing both agencies. These differences may lead to different access to treatment options. Hence, communication between the FDA and HC on harmonizing decision-making is needed.