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On July 24, 2026, the Committee will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: Emideltide (also referred to as delta sleeping inducing peptide (DSIP))-related bulk drug substances (Emideltide (free base)/ Emideltide acetate), Semax-related bulk drug substances (Semax (free base)/ Semax acetate), and Epitalon-related bulk drug substances (Epitalon (free base)/ Epitalon acetate)

As is the case with all intravenous infusions, febrile reactions, infections at the site of injection, venous thrombosis or phlebitis and extravasation may occur

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