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Diurnal Group Plc (DNL.L) Announced that an application for market authorisation for Alkindi (hydrocortisone granules in capsules for opening) has been submitted to the Australian Therapeutic Good Administration (TGA) for the indication "replacement therapy of adrenal insufficiency (AI) in infants, children and adolescents. Recently, Alkindi was granted Orphan Drug Designation in Australia, a valuable regulatory privilege that provides significant benefits, including waiver of application, evaluation and annual registration fees. Alkindi is already approved and marketed in Europe and is the first preparation of hydrocortisone, which is specifically designed for use in children suffering from AI, including the related condition CAH.
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