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New Drug Application (NDA): If clinical trials demonstrate that the drug is safe and effective, the sponsor submits an NDA to the FDA, which includes all data from the trials, labeling information, and manufacturing details

Ann Rheumatic Dis (2013) 72(6):1032

Tempia Valenta S, Nicastri A, Perazza F, Marcolini F, Beghelli V, Atti AR, et al

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Bremelanotide is essentially a refined metabolite of melanotan II, designed to maximize sexual effects while minimizing side effects