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

   

Hawthorn Pharmaceuticals, Inc. Receives FDA Approval on Granisol(TM) Oral Solution


3/13/2008 9:50:38 AM

MADISON, Miss.--(BUSINESS WIRE)--Hawthorn Pharmaceuticals, Inc. announced today the US Food and Drug Administration (FDA) approval of the company’s Granisol™ (granisetron HCl) Oral Solution. Granisol™ is an oral solution for the prevention of nausea and vomiting associated with cancer therapy. Granisol™ is the AA-rated equivalent of Roche’s Kytril® Oral Solution.

“According to the National Cancer Institute, oral mucositis occurs in almost all patients receiving radiation for head and neck malignancies, in more than 75% of bone marrow transplant recipients, and in nearly 40% of patients receiving chemotherapy,” said Chris Smith, Vice President of Sales. “We feel this product will fill an important need in helping to prevent nausea and vomiting associated with chemotherapy or radiation for cancer therapy patients who may have difficulty swallowing tablets.”

Granisol™ Oral Solution is available through all the national drug wholesalers as well as multiple other distribution channels and will begin shipping immediately. Granisol™ Oral Solution is available by prescription only in the United States.

IMPORTANT SAFETY INFORMATION:

Granisol™ (granisetron HCl) is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin and with radiation, including total body irradiation and fractionated abdominal radiation. The most frequently reported clinical adverse events occurring in >5% of patients receiving Granisol™ were headache, constipation, asthenia, and diarrhea. The use of Granisol™ in patients following abdominal surgery or in patients with chemotherapy induced nausea and vomiting may mask progressive ileus and/or gastric distention. For full prescribing information, visit www.hawthornrx.com/PIs/GranisolPI.pdf.

About Hawthorn Pharmaceuticals

Hawthorn Pharmaceuticals, Inc., founded in 1998, is a specialty pharmaceutical company that develops and markets prescription pharmaceutical products to multiple physician specialties. Hawthorn has a diverse product line marketed by its nationwide sales force. Hawthorn has an aggressive product development pipeline including multiple new drug applications (NDAs) in various stages of development. Hawthorn expects additional submissions with the Food and Drug Administration (FDA) to be approved in the first half of 2008. Additionally, Hawthorn has successfully signed several in-licensing agreements with multinational companies in the past several years and continues to utilize strategic alliances as part of its overall pharmaceutical pipeline. Visit www.hawthornrx.com for more information.

Contacts

Hawthorn Pharmaceuticals, Inc. Max Draughn, Chief Executive Officer, 888-455-5253



Read at BioSpace.com

   

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