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:6/24/2016)... June 24, 2016 Research ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural Health ... Structural electronics involves electronic and/or electrical ... structures, replacing dumb structures such as vehicle bodies ...
(Date:6/24/2016)... 24, 2016 Dehaier Medical Systems Ltd. (NASDAQ: ... develops, markets and sells medical devices and wearable sleep ... a strategic cooperation agreement with Hongyuan Supply Chain Management ... on June 20, 2016, to develop Dehaier,s new Internet ... agreement, Dehaier will leverage Hongyuan Supply Chain,s sales platform ...
(Date:6/24/2016)... Research and Markets has announced the addition of ... report to their offering. ... The World Market for Companion Diagnostics covers the world market ... the report includes the following: , World ... Region (N. America, EU, ROW), 2015-2020 , World IVD ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... , ... Those who have experienced traumatic events may suffer from a complex ... as drug or alcohol abuse, as a coping mechanism. To avoid this pain and ... a traumatic event. , Trauma sufferers tend to feel a range of emotions, from ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
(Date:6/24/2016)... ... , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys ... peers for this recognition are considered among the top 2 percent of lawyers practicing ... members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is ... Road To Recovery® program to drive cancer patients to and from their cancer treatments. ... the highest quality of life and ongoing independence. Getting to and from medical ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
Breaking Medicine News(10 mins):