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:10/4/2017)... LAWRENCE, Mass. , Oct. 4, 2017 /PRNewswire/ ... developer of single-use, self-contained, illuminating medical devices, today ... National Health Surveillance Agency (or Agência Nacional ... ®. The first single-use, cordless surgical retractor with ... ONETRAC provides optimal access, illumination and exposure of ...
(Date:10/2/2017)... , Oct. 2, 2017 The Rebound mobile ... the struggle to reverse the tide of prescription drug addiction. ... regulating their medicine intake and stepping down their dosage in ... to launch in December 2017; the first 100,000 people to ... more at http://www.rebound-solution.com/ ...
(Date:9/25/2017)... --  Montrium , an industry leader in powerful ... Trial Master Files & Inspection Readiness Conference ( ... Services has selected eTMF Connect to ... a leading European contract research organization (CRO), will ... enable greater collaboration with sponsors, improve compliance and ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and ... explains one of the most popular and least understood books in the Holy Scriptures, ... puzzling descriptions that have baffled scholars for centuries. Many have tossed it off as ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to ... to save lost souls in the Philippines. “The Journey: From the Mountains to the ... teacher of the Bible. She has taught all ages and currently teaches a class ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 million ... by frequent cessation in breathing. Oral appliances can offer significant relief to about ...
(Date:10/12/2017)... PALM CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... of cold therapy products, announced today the introduction of an innovative new design of ... the multipurpose pad so you get maximum comfort while controlling your pain while using ...
(Date:10/12/2017)... ... 2017 , ... Information about the technology: , Otomagnetics has ... prevention of a major side effect of chemotherapy in children. Cisplatin and carboplatin ... cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. Hearing ...
Breaking Medicine News(10 mins):