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

   

Handa Pharmaceuticals Announces Submission of its First-to-File ANDA for AstraZeneca PLC (AZN)'s SEROQUEL(R) XR


8/1/2008 10:42:17 AM

FREMONT, Calif., July 31 /PRNewswire/ -- Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application ("ANDA") for Quetiapine Fumarate Extended-Release Tablets, the generic version of AstraZeneca's SEROQUEL(R) XR, has been accepted for filing by the U.S. Food and Drug Administration ("FDA"). Based upon available information, Handa believes that it is the first applicant to file an ANDA for SEROQUEL(R) XR containing a Paragraph IV certification, under the provisions of the Hatch- Waxman Act. Should its ANDA be approved by the FDA, Handa believes that its product will be entitled to 180 days of generic market exclusivity.

About Handa Pharmaceuticals, LLC

Handa Pharmaceuticals, LLC is a specialty pharmaceutical company that was established in the San Francisco Bay area in November 2005. Handa's executive leadership has a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate. For more information, please visit http://www.handapharma.com.

Forward-Looking Statements

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Handa's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Handa disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Handa's current expectations depending upon a number of factors affecting Handa's business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and demand for Handa's products; difficulties or delays in manufacturing; and other risks and uncertainties.

SEROQUEL(R) and SEROQUEL(R) XR are registered trademarks of the AstraZeneca group of companies.

Contact: Stephen Cary of Handa Pharmaceuticals, LLC, +1-510-354-2888

CONTACT: Stephen Cary of Handa Pharmaceuticals, LLC, +1-510-354-2888

Web site: http://www.handapharma.com/



Read at BioSpace.com

   

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