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

Posted on

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

read all at

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

UPDATE………………….

 

L-DOPS.svg

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…

View original post 6,639 more words

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s