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Trials & Filings

NOH Treatment To Get Advisory Review

Chelsea's Northera to be reviewed in January 2014

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Chelsea Therapeutics International‘s treatment for symptomatic neurogenic orthostatic hypotension (NOH), Northera (droxidopa), will be reviewed by the FDA’s Cardiovascular and Renal Drug Advisory Committee (CRDAC). The meeting is tentatively scheduled for January 14, 2014. Northera is an orally active synthetic precursor of norepinephrine

The FDA recently assigned to Northera a Prescription Drug User Fee Act (PDUFA) goal date of February 14, 2014. Northera was previously granted Orphan Drug Designation and received Fast Track designation from the FDA. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.

Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd. (DSP), initially received Japanese approval in 1989 for the treatment of frozen gait and dizziness on standing associated with Parkinson’s Disease and for the treatment of orthostatic hypotension, syncope or dizziness on standing associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy. In 2000, Droxidopa received expanded marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.

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