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Novo Nordisk announced FDA acceptance of their New Drug Application (NDA) for a 25 mg oral version of Wegovy for two new indications: (1) chronic weight management in adults living with obesity or who are overweight with at least one comorbid condition, and (2) to reduce the risk of MACE in adults with overweight or obesity and established CVD
A: Lyophilized means freeze-dried to improve stability during storage
Drug interactions must also be considered
Adding a minor secondary ingredient (e.g., Vitamin B12) to an unapproved peptide does not legally differentiate it or create a compliant formulation
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