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

8 09 2013

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

Actions

Information

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




Green Chemistry @ MUN

Less solvent, Less waste, Less energy

Inspiring Science

Casting light on great ideas

Your mom is like science?

Practical scientific analogy education and outreach

DRUG REGULATORY AFFAIRS INTERNATIONAL

Drug Regulatory affairs by DR ANTHONY MELVIN CRASTO, Worlddrugtracker

Syntheticnature

Total Synthesis and general organic chemistry

pharmupdates.wordpress.com/

News and articles on the Pharmaceutical Industry

Combinatorics and more

Gil Kalai's blog

Organic chemistry teaching

Just another WordPress.com weblog

Seven Spheres

Aqua Terra Ignis et Aer

The Molecular Circus

How molecules make the world go round

Chemtips

Because Organic Chemistry is Hard Enough

The Heterocyclist

A blog about heterocyclic chemistry

travellingbeets

Travelling Stories & Photographs From One Travel Lover To Another

The Sacred Lives of Objects

Seeing and Being Seen in the Modern Museum

Earth mY homE

Seeing the Surroundings

One Person, One World.

Tibet, Human Rights, Injustice, Animal Abuse, Child Abuse

France Outdoors

Experience Culture, Physical Activity and Nature on Every Trip

Grind Your Wheat

a chronicle of our nomadic wanderings

Green Chemistry @ MUN

Less solvent, Less waste, Less energy

Inspiring Science

Casting light on great ideas

Your mom is like science?

Practical scientific analogy education and outreach

DRUG REGULATORY AFFAIRS INTERNATIONAL

Drug Regulatory affairs by DR ANTHONY MELVIN CRASTO, Worlddrugtracker

Syntheticnature

Total Synthesis and general organic chemistry

pharmupdates.wordpress.com/

News and articles on the Pharmaceutical Industry

Combinatorics and more

Gil Kalai's blog

Organic chemistry teaching

Just another WordPress.com weblog

Seven Spheres

Aqua Terra Ignis et Aer

The Molecular Circus

How molecules make the world go round

Chemtips

Because Organic Chemistry is Hard Enough

The Heterocyclist

A blog about heterocyclic chemistry

travellingbeets

Travelling Stories & Photographs From One Travel Lover To Another

The Sacred Lives of Objects

Seeing and Being Seen in the Modern Museum

Earth mY homE

Seeing the Surroundings

One Person, One World.

Tibet, Human Rights, Injustice, Animal Abuse, Child Abuse

France Outdoors

Experience Culture, Physical Activity and Nature on Every Trip

Grind Your Wheat

a chronicle of our nomadic wanderings

Green Chemistry @ MUN

Less solvent, Less waste, Less energy

Inspiring Science

Casting light on great ideas

Your mom is like science?

Practical scientific analogy education and outreach

DRUG REGULATORY AFFAIRS INTERNATIONAL

Drug Regulatory affairs by DR ANTHONY MELVIN CRASTO, Worlddrugtracker

Syntheticnature

Total Synthesis and general organic chemistry

pharmupdates.wordpress.com/

News and articles on the Pharmaceutical Industry

Combinatorics and more

Gil Kalai's blog

Organic chemistry teaching

Just another WordPress.com weblog

Seven Spheres

Aqua Terra Ignis et Aer

The Molecular Circus

How molecules make the world go round

Chemtips

Because Organic Chemistry is Hard Enough

The Heterocyclist

A blog about heterocyclic chemistry

travellingbeets

Travelling Stories & Photographs From One Travel Lover To Another

The Sacred Lives of Objects

Seeing and Being Seen in the Modern Museum

Earth mY homE

Seeing the Surroundings

One Person, One World.

Tibet, Human Rights, Injustice, Animal Abuse, Child Abuse

France Outdoors

Experience Culture, Physical Activity and Nature on Every Trip

Grind Your Wheat

a chronicle of our nomadic wanderings

%d bloggers like this: