Chelsea Therapeutics Announces FDA Advisory Committee to Review Northera

barbara.lempert

FDA to (droxidopa)

          Panel Date Tentatively Set for January 14, 2014

CHARLOTTE, N.C., Oct. 9, 2013 (GLOBE NEWSWIRE) — Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the New Drug Application (NDA) seeking approval to market NORTHERA(TM) (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension
(NOH) will be reviewed by the Cardiovascular and Renal Drug Advisory Committee (CRDAC). The meeting is tentatively scheduled for January 14, 2014.

The FDA recently assigned to NORTHERA(TM) a Prescription Drug User Fee Act (PDUFA) goal date of February 14, 2014. NORTHERA(TM) 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.

About Symptomatic NOH

NOH is a chronic neurogenic disorder resulting from deficient release of norepinephrine that predominantly affects patients with primary autonomic failure, a group of diseases which includes Parkinson’s disease (PD), multiple system atrophy (MSA) and pure autonomic failure (PAF). Symptoms of NOH include: dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and fainting episodes when a person assumes a standing position, often severely limiting a person’s ability to perform routine daily activities that require standing or walking for both short and long periods of time.

About Northera

NORTHERA(TM) (droxidopa), the lead investigational agent in Chelsea Therapeutics’ pipeline, is currently in Phase III development for the treatment of symptomatic neurogenic orthostatic hypotension…Read more

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