This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Intravenous Remodulin Approved For The Treatment Of Pulmonary Arterial Hypertension In Most Of The European Union





SILVER SPRING, Md. and CHERTSEY, England, Dec. 27, 2011 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) and its wholly-owned subsidiary, United Therapeutics Europe, Ltd., announced today that the French regulatory agency Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) has approved intravenous use of Remodulin® (treprostinil) for the treatment of pulmonary arterial hypertension (PAH).  Remodulin is already approved in most of Europe for the continuous subcutaneous infusion treatment of idiopathic or heritable PAH to improve exercise tolerance and symptoms of the disease in patients classified as New York Heart Association (NYHA) functional class III.  The AFSSAPS' approval follows a review period during which 22 European member nations, each of which had previously approved subcutaneous Remodulin through the mutual recognition process, reviewed and endorsed the final variation assessment report (FVAR) issued by AFSSAPS, which will allow the use of the intravenous route of delivery to the Remodulin in the labeling in those nations.

"It is with great satisfaction that intravenous use of Remodulin will now be available to PAH patients in Europe," said Roger A. Jeffs, Ph.D., President and Chief Operating Officer.  "This approval significantly expands the treatment options for PAH patients using parenteral therapy in Europe."

In Europe, risk management plans (RMPs) are routinely required as part of the regulatory approval process for new medicines and also for significant variations involving a change to the route of administration, formulation or indication.  For intravenous Remodulin, United Therapeutics will implement an RMP focused on minimizing the known risks of central venous catheter-related blood stream infections associated with intravenous administration.

Oral Treprostinil New Drug Application Submitted to the FDA

United Therapeutics also announced today that it submitted to the U.S. Food and Drug Administration a New Drug Application (NDA) for treprostinil diethanolamine sustained release tablets (oral treprostinil) for the treatment of PAH on December 27, 2011.  The submission starts a 60-day period during which the FDA will examine the application for completeness.  If the FDA accepts the NDA for review, then it is expected to be subject to the standard review period of 10 months from the submission date, before an action letter is issued.  



1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,080.54 +56.48 0.31%
S&P 500 2,108.29 +22.78 1.09%
NASDAQ 5,005.3910 +63.9670 1.29%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs