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Treatment with Basaglar was found to be noninferior to insulin glargine U-100 products in reducing A1C from baseline (adjusted mean change from baseline = -1.3 for both treatment arms

If the pen is already in use and the room temperature stayed between 59 and 86 degrees Fahrenheit, Ozempic is approved for room temperature storage for up to 56 days

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This is a legal and regulated category of pharmaceutical practice - but the oversight structure is fundamentally different from the new drug approval pathway that applies to commercially manufactured medications