In the Phase 2 clinical trial, obese patients treated with a 12-milligram dose for 48 weeks experienced an average weight reduction of 24.2% (approximately 58 pounds/26.2 kilograms), significantly better than the 2.1% reduction in the placebo group
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Step 8: FDA inspections and approvals This process, which would require 6 to 10 months, would involve filing an Abbreviated New Drug Application (ANDA) for generic drugs or a New Drug Application (NDA) for a new drug, Step 9: Commercial production launch At this point, the pharmaceutical company can begin full-scale production and distribution in the U.S
The food supplement cannot be used as a food substitute
[1] [2] Patients with a history of diabetic retinopathy require careful consideration, as the SUSTAIN-6 trial identified a higher incidence of retinopathy complications in the semaglutide group, particularly in those with pre-existing retinopathy and rapid improvement in blood glucose control
