FDA gives tentative approval to Mylan's Topamax generic

WASHINGTON Mylan Pharmaceuticals has received tentative approval from the Food and Drug Administration for its application for Topiramate capsules.

Topiramate capsules are the generic version of Ortho McNeil Pharmaceuticals Topamax sprinkle capsules. The new generic will be available in 15 and 25 mgs. The drug had sales of approximately $46 million in the U.S. for the 12 months ending June 30, 2007.

Topamax is used as a mood stabilizer for people with bipolar disorder.