Chelsea Therapeutics Resubmits New Drug Application for NORTHERA(TM) (droxidopa) for the Treatment of Symptomatic NOH

10 07 2013

New Drug Approvals

Droxidopa

 

Submission Includes Successful 300 mg Bioequivalence Study

*  Six Month Review Decision Expected Under PDUFA

July 9, 2013

— Chelsea Therapeutics International, Ltd. today announced that it resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market NORTHERA(TM) (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.

http://www.pharmalive.com/chelsea-resubmits-northera-nda

 

L-DOPS (L-threo-dihydroxyphenylserine; DroxidopaSM-5688) is a psychoactive drugand synthetic amino acid precursor which acts as a prodrug to the neurotransmittersnorepinephrine (noradrenaline) and epinephrine (adrenaline).[1] Unlike norepinephrine and epinephrine themselves, L-DOPS is capable of crossing the protective blood–brain barrier(BBB)

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