Chelsea Therapeutics confirms FDA approval of Northera, halt lifted at 5:25
The FDA confirms it approved Chelsea Therapeutics' (CHTP) Northera capsules for the treatment of neurogenic orthostatic hypotension.
Northera will contain a boxed warning to alert doctors and patients about applicable risks, and the package insert indicates that effectiveness beyond two weeks of treatment has not yet been demonstrated, but there's no restriction on prescription use.
CHTP calls the approval "an extraordinary achievement."
Shares to resume trading at 5:25.
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Tuesday, Feb 18
4:49 PM
Chelsea's Northera NDA reportedly approved, shares halted
Chelsea Therapeutics (CHTP) is halted; multiple sources say Northera was approved by the FDA, but there's still no official press release from the FDA or the company.
A decision for the Northera new drug application was postponed from last Friday due to an office closure caused by severe weather.
