Advertisement
The Body: The Complete HIV/AIDS Resource
Follow Us Follow Us on Facebook Follow Us on Twitter Download Our App
Professionals >> Visit The Body PROThe Body en Espanol
  Breaking News: FDA Approves Triumeq, New Once-Daily Combination Pill
  
  • Email Email
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

International News

Ranbaxy Gets U.S. FDA Approval for Generic AIDS Drug

May 31, 2005

Ranbaxy Laboratories today became the first Indian drug company to gain regulatory approval for a generic AIDS drug to be included in the $15 billion President's Emergency Plan for AIDS Relief (PEPFAR). The U.S. Food and Drug Administration (FDA) has granted Ranbaxy tentative approval to make and market lamivudine tablets as part of the program. Ranbaxy is seeking FDA approval of four antiretrovirals so they can be included in the program. In November, Ranbaxy pulled all its AIDS drugs from the World Health Organization's list of approved drugs after finding discrepancies in tests that had been undertaken to show that the generics were the equivalents of the brand name drugs. The company has since submitted 11 antiretrovirals for WHO approval.

Back to other news for May 31, 2005

Adapted from:
Reuters
05.31.05


  
  • Email Email
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

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.
 
See Also
More on Generic/Discount HIV Drug Access in the Developing World

Tools
 

Advertisement