Posted by Michael Wonder on 13 Feb 2020
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.
