FDA reviewer advises against Northera approval, but says decision 'debatable'
This article was originally published in Scrip
The decision whether to permit Chelsea Therapeutics to market its drug Northera (droxidopa) in the US as a treatment to improve symptoms of neurogenic orthostatic hypotension (NOH), a chronic neurogenic disorder resulting from deficient release of norepinephrine, is "debatable," given there has been no durable effect demonstrated with the medicine and its safety profile is unclear, a US FDA drug reviewer said, ultimately advising against approval.
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