Navigation Links
Arbor Pharmaceuticals Announces Filing of First NDA
Date:12/1/2011

ATLANTA, Dec. 1, 2011 /PRNewswire/ -- Arbor Pharmaceuticals announced today that it has filed its first New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).  The recently filed product has been granted an Orphan designation by the FDA which provides seven years of market exclusivity. In addition, the FDA has granted Fast Track review status for this product primarily due to the safety advantages it offers. Fast Track review shortens the normal twelve month review period to six months. 

Ed Schutter, President & CEO of Arbor stated, "I am pleased that our first NDA filing could be accomplished so early in our brief company history. I am excited about the market potential for this product as well as our other products in development. We could not have accomplished this without the leadership and dedication of Dr. Downey and his team."

Dr. Laurence Downey, VP of Medical & Scientific Affairs added, "Filing of our initial NDA with the FDA is an important milestone in the evolution of Arbor Pharmaceuticals. This is the first of what we hope will be multiple NDA filings over the next several years. I would like to thank and congratulate our team that worked tirelessly to file this submission on a timely basis."

Arbor has over 130 sales professionals in the field which promote its products to hospitals and physicians.  The company expects to launch the new product to the hospital market in mid-2012. Arbor continues to actively seek other marketed and late stage products to acquire in this segment as well as other specialty focused areas complementary to its business. 

About Arbor Pharmaceuticals

Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the cardiovascular and pediatric markets. The company intends to become a leading specialty pharmaceutical company by actively licensing, developing and commercializing late-stage products for specialty focused conditions. Arbor currently markets multiple NDA and ANDA approved products with several more in development.

For more information regarding Arbor Pharmaceuticals or any of its products, visit www.arborpharma.com or send email inquiries to info@arborpharma.com.

 

 

 

 


'/>"/>
SOURCE Arbor Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Brio Device Awarded Best of Ann Arbor SPARKs Boot Camp
2. Renaissance Surgical Arts at Newport Harbor Announces Single-Dose Radiation Treatment Alternative for Women with Early Breast Cancer
3. Arbor Pharmaceuticals Completes $34.8 Million Financing
4. DATATRAK Secures Safe Harbor Certification for EU and Switzerland
5. Quantum Signal and Delphinus Medical Technologies Awarded MEGA Funding to Expand in Ann Arbor Area
6. Arbor Pharmaceuticals Announces the Launch of Pediaderm(TM) HC Complete Kit - A Comprehensive Approach to the Management of Atopic Dermatitis
7. Harbor BioSciences to Receive Patent for Apoptone(R) Cancer Treatment
8. Hollis-Eden Announces Name Change to Harbor BioSciences, Inc. and Ticker Symbol Change to HRBR
9. Cold Spring Publishing, LLC, Changes Name to Harborside Press, LLC
10. Harborside Healthcare to Pay U.S. $1.375 Million to Resolve Allegations of Kickbacks and Sham Durable Medical Services
11. J. Craig Venter, Ph.D. Receives Double Helix Medal from Cold Spring Harbor Laboratory
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... , Dec. 8, 2016 IRIDEX Corporation (NASDAQ: ... offer newly issued shares of common stock, $0.01 par value ... an underwritten public offering.  The final terms of the Offering ... of pricing, and there can be no assurance as to ... IRIDEX expects to use the net proceeds it will receive ...
(Date:12/8/2016)... -- Global Interventional Radiology Market: Scope and Methodology ... market analyzes the current and future prospects of ... summary, including a market snapshot that provides overall ... research is a combination of primary and secondary ... research efforts along with information collected from telephonic ...
(Date:12/8/2016)... 2016  Eli Lilly and Company (NYSE: ... 3 EXPEDITION3 trial at the 9 th Clinical ... solanezumab did not meet the primary endpoint in the ... people with mild dementia due to Alzheimer,s disease (AD), ... for the treatment of mild dementia due to AD. ...
Breaking Medicine Technology:
(Date:12/8/2016)... San Francisco, California (PRWEB) , ... December 08, 2016 , ... ... health coaches, has raised an $18M Series B led by Canvas Ventures . ... use the capital to scale its mobile platform to serve more consumers who are ...
(Date:12/8/2016)... ... December 08, 2016 , ... The Dan Carlisle Agency, ... Jefferson County, is announcing the launch of a charity drive to raise support ... homeless women and children in Birmingham has grown steadily since the 1980’s, and ...
(Date:12/8/2016)... , ... December 08, 2016 , ... The Compretta Insurance ... and residential clients in and around the Hancock County area, is announcing the launch ... County Food Pantry. , The Hancock County Food Pantry has worked for more than ...
(Date:12/7/2016)... (PRWEB) , ... December 07, 2016 , ... DrugDev ... the announcement that it is one of the early adopters completing EU-U.S. Privacy Shield ... is designed to provide companies on both sides of the Atlantic with a mechanism ...
(Date:12/7/2016)... Kenosha, Wisconsin (PRWEB) , ... December 07, 2016 , ... ... the extraordinary new MedMaster™ MPCNGX . The MPCNGX is a multi-function, sealed, LED ... the right amount of light where and when it’s needed. , A ...
Breaking Medicine News(10 mins):