FDA: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A January 2025 guidance explaining Category 1, the interim enforcement policy, and development of the formal list
It appears Novo was tripped up by manufacturing issues, as the company said the FDA made requests related to the manufacturing process in its Complete Response Letter
Headline points: Both compounds independently produce dose-related nausea, vomiting, constipation, and decreased appetite
Use for weight loss medication in non-diabetic patients should be considered with caution and under medical supervision, as there are factors unique to each individual that must be considered
Beyond liver concerns, alcohol can worsen side effects like dryness, rash, and mood changes
Together, these functions can help decrease your appetite, causing you to eat less food and lose more weight