News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Swedish Specialty Pharmaceutical Company Orexo AB Announced Today the Submission of a New Drug Application for Zubsolv™ (OX219) to the FDA


9/6/2012 10:40:21 AM

UPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News: Orexo (STO:ORX) is the first company to submit a New Drug Application (NDA) for a novel combination product of buprenorphine and naloxone for treatment of opioid dependence, a condition affecting over two million Americans. The development of Zubsolv (OX219), a product comprising buprenorphine and naloxone based on Orexo’s proprietary sublingual drug delivery technology, has progressed well and faster than originally anticipated. A total of four clinical studies were completed in support of the filing, along with a CMC product stability program covering two independent manufacturing sites.

Read at BioSpace.com


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES