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It is the form naturally present in the human body and in animal products

FDA staff's own briefing document, posted publicly ahead of the meeting as part of the docket, proposes that TB-500 (free base) and TB-500 acetate not be added to the list, citing incomplete physicochemical characterization, a lack of evidence of effectiveness for wound healing (including an in-vitro fibroblast study in which TB-500 reportedly did not induce wound healing), and insufficient nonclinical and clinical safety data

Orange Book patent listings are the single most powerful tool a brand manufacturer has to delay generic entry under the Hatch-Waxman Act, because listing a patent forces any ANDA applicant to certify against it or wait