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:6/7/2017)... , June 7, 2017  Novavax, Inc., (Nasdaq: ... two Phase 2 trials of its RSV F protein recombinant ... bearing age have been published in the journal ... been shared in prior scientific conferences). The Company previously announced ... 2014. Novavax is developing the RSV F Vaccine with the ...
(Date:6/5/2017)... The Cincinnati location of Diplomat Specialty ... has been awarded a Top Workplaces 2017 honor ... based on an employee survey administered by WorkplaceDynamics, LLC, a ... survey measures several aspects of workplace culture, including alignment, execution, ... ...
(Date:6/3/2017)... 2017  Eli Lilly and Company (NYSE: ... the Phase 3 MONARCH 2 study showed that ... in combination with fulvestrant, significantly improved progression-free survival ... women with hormone-receptor-positive (HR+), human epidermal growth factor ... relapsed or progressed after endocrine therapy (median PFS, ...
Breaking Medicine Technology:
(Date:6/20/2017)... ... June 20, 2017 , ... With certifications and experience that ... Denville, NJ, Drs. Adam and Hal Kimowitz are currently accepting new patients at their ... orthodontics can cause for some patients, which is why they offer the latest in ...
(Date:6/20/2017)... (PRWEB) , ... June 20, 2017 , ... Uniform ... scrub collection featuring seven new products designed to create tailored looks and athleisure-inspired outfits. ... polyester and cotton easy care stretch twill. , With trendy looks hitting the medical ...
(Date:6/20/2017)... ... June 20, 2017 , ... ... bedside, would like to officially welcome Anthony Stanowski, DHA, FACHE to the MEDI+SIGN ... whose insight and expertise in healthcare will provide invaluable direction for the company,” ...
(Date:6/19/2017)... New York, NY (PRWEB) , ... June 19, 2017 , ... ... and this year, it’s going to be a humdinger. A warm winter and wet ... devour summer wedding guests. “No one wants to be swatting away pesky mosquitoes when ...
(Date:6/19/2017)... ... June 19, 2017 , ... StratusLIVE, LLC, a leading provider ... new and improved features to their Workplace Giving platform including an all ... of national campaigns. The latest release also includes enhancements to dashboards, reporting, ...
Breaking Medicine News(10 mins):