Chelsea Therapeutics Announces FDA Acceptance of NORTHERA(TM) (droxidopa) NDA Resubmission

New Drug Approvals

Droxidropa

 

FDA Deems Resubmission a Complete Response; PDUFA Date Set as
February 14, 2014

CHARLOTTE, N.C., Sept. 4, 2013 (GLOBE NEWSWIRE) — Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission seeking approval to market NORTHERA(TM) (droxidopa), an orally active synthetic precursor of norepinephrine

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http://www.pharmalive.com/chelsea-therapeutics-announces-fda-acceptance-of-northera-nda-resubmission

UPDATE………………….

 

DROXIDOPA

ORPHAN DRUG,

CAS 23651-95-8, 3916-18-5

ROTATION   –FORM

(2S,3R)-2-amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid

223-480-5[EINECS],

L-Tyrosine, β,3-dihydroxy-, (βR)-, L-Tyrosine, β,3-dihydroxy-, threo-

Northera[Trade name]

threo-b,3-Dihydroxy-L-tyrosine

1-14-00-00685[Beilstein], L-threo-3-(3,4-Dihydroxyphenyl)serine, L-Dihydroxyphenylserine, L-DOPS;DOPS, \

Northera, C, L-DOPS|Northera®, |SM-5688, L-threo-dihydroxyphenylserine, L-Threodops

L-threo-droxidopa, threo-2-Amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropionic acid

THREO-DIHYDROXYPHENYLSERINE

threo-Dopaserine

UNII:24A0V01WKS

UNII:J7A92W69L7

FDA 2/18/2014, FDA approves Northera to treat neurogenic orthostatic hypotension

Properties: Crystals from ethanol and ether, mp 232-235° (dec).

[a]D20 -39° (c = 1 in 1N aq HCl).

Also cited as crystals from water and L-ascorbic acid, mp 229-232° (dec) (Ohashi). [a]D20…

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