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

   

Skyepharma PLC (SKYE) Announces Research Update; FDA Extends Review Period for Requip(R)


2/5/2008 6:54:02 AM

LONDON, UK, 5 February 2008-- SkyePharma PLC (LSE:SKP.L - News) has been informed that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for GlaxoSmithKline's Requip(R) XLTM Extended Release tablets.

The PDUFA action date is the date by which the FDA is expected to issue a response on a pending new drug application. Following the approvable letter for Requip XL issued in December 2007, GlaxoSmithKline submitted a response to the FDA. A final decision from the FDA had been expected in Q1 2008. However, GSK has recently submitted additional information on food effect to the FDA. The Agency has determined that they would not have sufficient time to review this information prior to the Q1 action date and the final decision is now expected to be received in Q2 2008.

Requip(R) XLTM is the first and only once-daily oral non-ergot dopamine agonist indicated to treat the signs and symptoms of idiopathic Parkinson's disease. It uses SkyePharma's patented GEOMATRIXTM technology and has been designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. The product is expected to be available in pharmacies shortly after the anticipated approval.

SkyePharma PLC is pleased to note the launch in France last week of Requip(R) LP Extended Release tablets (as Requip(R) XLTM Extended Release tablets are known in France).

For further information please contact:

SkyePharma PLC Frank Condella +44 20 7491 1777

About SkyePharma PLC

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Company has twelve approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies.

For more information, visit http://www.skyepharma.com

About GlaxoSmithKline

Ropinirole Extended-Release Tablets have been approved in 13 European countries and are marketed by GlaxoSmithKline under the brand names Requip XL, Requip Modutab, Requip LP and Requip Depot. GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. More information on GlaxoSmithKline is available at the company's website at http://www.gsk.com.



Read at BioSpace.com

   

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