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Legally, it is a full New Drug Application (NDA) that allows the FDA to rely on data the applicant did not generatespecifically, the safety and efficacy findings for an already approved Reference Listed Drug (RLD)

Nausea (particularly during early dosing), facial flushing, and pigmentation changes in moles or freckles are most commonly reported

Our medical team takes extra precautions when treating patients with compromised immune systems or clotting disorders, as these conditions may increase risks related to IV insertion sites and potential infections

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