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The label language, REMS conditions, and companion diagnostic requirements that come out of the FDA review process often matter more than the absolute approval timeline

Current Canadian pricing for established GLP-1 medications remains substantial: Mounjaro: Approximately $300-400 monthly depending on dose Zepbound: Similar pricing structure to Mounjaro Ozempic: $200-300 monthly across different strengths Wegovy: $400-500 monthly for maintenance doses Regulatory Pathway in Canada For Pfizer's long-acting GLP-1 drug to reach Canadian patients, the company must complete clinical trials and submit a New Drug Submission to Health Canada

Participants in trials like STEP 1 tend to have extreme obesity (average BMI 38) and receive extensive support (including regular lifestyle counseling (source))