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In a recent news release, the manufacturer announced the submission of a new drug application to the US Food and Drug Administration (FDA) and a marketing authorisation application to the European Medicines Agency (EMA) for tirzepatide for the treatment of adults with type 2 diabetes [12]
Ni L, Llewellyn R, Kesler CT, Kelley JB, Spencer A, Snow CJ, et al
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FDA treats a free base and an acetate salt as distinct bulk drug substances
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