BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Salix Pharmaceuticals, Ltd. (SLXP) Announces Acceptance Of NDA Filing For Budesonide Foam In Patients With Distal Ulcerative Colitis


1/30/2014 11:55:33 AM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

RALEIGH, N.C.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and Drug Administration (FDA) has accepted for filing a New Drug Application (NDA) for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. The FDA has issued an action date of September 15, 2014 under the Prescription Drug User Fee Act (PDUFA). Bill Forbes, Executive Vice President, Medical and Research and Development and Chief Development Officer, Salix, stated, “Patients with distal ulcerative colitis, also known as proctitis or proctosigmoiditis, are often difficult to treat and present the most challenging subset of patients given the limitations of available treatment options. For these patients with disease limited to the rectum and sigmoid areas of the colon, treatment with currently approved oral therapies is often ineffective due to insufficient distribution of active drug to the distal colon. Distal ulcerative colitis remains an unmet medical need, and we believe the availability of a rectally administered corticosteroid such as budesonide foam may help overcome limitations of existing products to treat this condition.”

Help employers find you! Check out all the jobs and post your resume.


Read at BioSpace.com

   

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