logo
  Join        Login             Stock Quote

Genzyme Says European Commission Approves Expanded Indication For Use Of Thyrogen

 December 07, 2012 07:54 AM
 


Genzyme, a Sanofi company (NYSE: SNY) said the European Commission approved the expanded indication for use of Thyrogen.

European Commission approved a product label expansion for the use of Thyrogen with a wider irradiation dose range for postoperative thyroid remnant ablation.

According to Genzyme, the revised indication in remnant ablation provides physicians with the option to administer a reduced dose of radioiodine (131-I). Previously the amount of radioiodine was specified at 100 mCi, whereas physicians may now select a dose from the range of 30 to 100 mCi.

"The expanded Thyrogen indication provides a new option for many physicians who may be reducing radioiodine use due to uncertainty about impact on recurrences and mortality in low-risk patients as well as short- and long-term safety concerns," said Professor Martin Schlumberger, Institut Gustave Roussy, University Paris Sud, Paris, France.

[Related -Sanofi SA (SNY): FDA Licenses New Four-Strain Influenza Vaccine]

The approval for the expanded indication for use of Thyrogen in Europe is based on the results of the two largest studies, which showed 30 mCi of radioiodine were well tolerated.

Thyrogen is approved as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging.

In the U.S. and Europe, Thyrogen is also approved as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer.

iOnTheMarket Premium
Advertisement

Advertisement


Post Comment -- Login is required to post message
Name:  
Alert for new comments:
Your email:
Your Website:
Title:
Comments:
 

rss feed

Latest Stories

article imageChipotle Mexican Grill, Inc. (CMG) Q2 Earnings Preview: Will Higher Traffic Offset Higher Costs the Key

Chipotle Mexican Grill, Inc. (NYSE:CMG) will host a conference call to discuss second quarter 2014 read on...

article imageNetflix, Inc. (NFLX) Q2 Earnings Preview: The Ruby Month for a Reason

Netflix, Inc. (NASDAQ:NFLX) will post its second-quarter 2014 financial results and business outlook on its read on...

article imageLadenburg Thalmann Financial Services (NYSEMKT:LTS): Heavy, Durable Insider Buying

Ahh, but any worries over price levels didn’t stop multiple insiders at Ladenburg Thalmann Financial read on...

article imageInternational Business Machines Corp. (IBM) Q2 Earnings Preview: Small Beat and Pop

International Business Machines Corp. (NYSE:IBM) will host a conference call Wednesday, Jul. 16, 2014 at read on...

Advertisement
Popular Articles

Advertisement
Daily Sector Scan
Partner Center



Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.