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Between now and those two dates, expect the agency to continue updating the 503A bulks reference document as nominations come in, get withdrawn, get clarified, and shift between categories

Clin Sci (London England: 1979)

Why an 8% Pill Matters: For a patient who has severe needle phobia, lacks reliable refrigeration for injectables, or travels frequently, a drug that achieves 20% weight loss in trials but goes unused is far less effective than an 8% pill taken consistently every day

In December, the FDA took tirzapetide off its shortages list