'Technical deficiencies' hang up Chelsea’s Northera; PDUFA clock stopped
This article was originally published in Scrip
The patience of Chelsea Therapeutics investors got another test on 29 July when the company revealed the FDA had discovered a problem with the firm's resubmitted new drug application (NDA) for Northera (droxidopa), in which regulators had identified certain technical deficiencies that need to be resolved before the agency considers moving forward on its review.
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