updated 12/21/2005 6:51:27 PM ET 2005-12-21T23:51:27

A generic version of a pediatric AIDS drug received preliminary approval Wednesday from the Food and Drug Administration.

  1. Don't miss these Health stories
    1. Splash News
      More women opting for preventive mastectomy - but should they be?

      Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

    2. Larry Page's damaged vocal cords: Treatment comes with trade-offs
    3. Report questioning salt guidelines riles heart experts
    4. CDC: 2012 was deadliest year for West Nile in US
    5. What stresses moms most? Themselves, survey says

The FDA said it was giving tentative approval for Stavudine, an antiretroviral drug considered child-friendly that is manufactured by Aurobindo Pharma Ltd. of Hyderabad, India.

Stavudine for oral solution is the first generic version of the previously approved Zerit for oral solution manufactured by Bristol-Myers Squibb.

The generic version meets FDA manufacturing, safety and efficacy standards but will not be marketed in the United States for patent exclusivity reasons, the agency said.

The approval does mean, however, that the generic version can be used by relief organizations outside the United States funded by President Bush's $15 billion AIDS relief plan.

© 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


Discussion comments


Most active discussions

  1. votes comments
  2. votes comments
  3. votes comments
  4. votes comments