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Here's the complete regulatory history: FDA Approval Timeline Date Event Details November 10, 2010 Original FDA Approval Egrifta approved for HIV-associated lipodystrophy (reduction of excess abdominal fat in HIV-infected patients with lipodystrophy) September 2019 Egrifta SV Approval Date Single-vial reformulation approved (simplified reconstitution vs

ONC updated the Demographics certification criterion (45 CFR 170.315(a)(5)), including renaming the ( criterion to Patient demographics and observations (89 FR 1295 and 1296)

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