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Thymosin Beta-4 (TB4) Strength: 5 mg Entry-strength peptide option for patients exploring repair and recovery-centered protocols

With respect to the newness criterion at 419.66(b)(1), FDA granted the applicant 510(k) clearance for the Axoguard HA+ Nerve Protector TM on April 7, 2023, and then granted a second 510(k) clearance for an expanded indication on October 12, 2023

Containing the TyrAsnTrpAsnSerPheGlyLeuArgPheNH2 peptide sequence, this formulation is supplied as a lyophilized powder in sterile, sealed vials at research-grade purity, designed for use in controlled laboratory settings

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