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ArticleFDA Updates

FDA approves first generic Liraglutide for obesity treatment

The U.S. FDA approved Teva Pharmaceuticals’ generic version of liraglutide (Saxenda®), the first generic GLP-1 receptor agonist for chronic weight management.

Indication: It is indicated for adults with obesity (BMI ≥30) or overweight (BMI ≥27 with comorbidity) and for adolescents aged 12–17 years with obesity.

Dose: 0.6 mg once daily SC, titrated weekly to a maintenance dose of 3 mg SC daily.

Mechanism: Liraglutide mimics GLP-1, enhancing insulin secretion, slowing gastric emptying, promoting satiety, and reducing appetite.

Common side effects: nausea, vomiting, diarrhea, headache, and injection-site reactions. Serious risks include pancreatitis, gallbladder disease, and thyroid C-cell tumors.

This approval is expected to lower treatment costs, compared to the branded Saxenda (~$1,350/month), and broaden access to effective obesity therapy.

Reference: FDA.gov
Clinical Inshorts  by ClinicHours

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