Print this page    •   Back to Web version of article

International News
Avexa Reaches Agreement With U.S. Regulator

March 31, 2011

Australia's Avexa Ltd. says its new agreement with the US Food and Drug Administration means the "regulatory pathway to final approval" of its HIV drug apricitabine (ATC) has been agreed upon. "Most importantly, the FDA has recognized and given credit for the significant amount of previous ATC clinical studies conducted by Avexa, in particular the latest ATC study AVX-301," the company said. "As a consequence, the remaining regulatory requirements for an ATC approval are considerably less complicated and less extensive than previously assumed, and less than that required for other recently approved drugs." Avexa said its research has shown "great potential" for the use of ATC in patients with multidrug-resistant HIV.

Back to other news for March 2011

Excerpted from:
Australian Associated Press
03.28.2011




This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. You can find this article online by typing this address into your Web browser:
http://www.thebody.com/content/art61302.html

General Disclaimer: TheBody.com is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through TheBody.com should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.