Diurnal Group’s new drug application accepted by the US FDA


13 February 2020 - Diurnal Group announced on Thursday that the US FDA accepted its new drug application for review.

The UK-based specialty pharma company is seeking approval of Alkindi Sprinkle as a replacement therapy of adrenal insufficiency in infants, children and adolescents in the US.

Diurnal Group said the drug could potentially be approved in Q3 of 2020, citing a PDUFA date set by the FDA of 29 September 2020.

Read Diurnal press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier