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 US for patent exclusivity reasons, the agency said. The approval means, however, that the generic version can be used by relief organisations outside the US, funded by US president George W Bush's US $15 billion (euro 12.6 billion) AIDS relief plan.
