FDA Accepts NDA for Northera
The FDA will review and act on the application for the drug, designed to treat symptomatic neurogenic orthostatic hypotension, by 28 March 2012.
The US FDA has accepted the filing of a new drug application for Northera (droxidopa), designed to treat symptomatic neurogenic orthostatic hypotension.
Northera, a synthetic catecholamine from Chelsea Therapeutics, will increase the levels of norepinephrine, both centrally and peripherally.
In previous Phase II trials, Northera has demonstrated clinical benefits in treating both intradialytic hypotension and adult attention deficit hyperactivity disorder, and is now being evaluated in an ongoing Phase II trial for the treatment of fibromyalgia.
As per the Prescription Drug User Fee Act, the FDA will review and act on the application by 28 March 2012.
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