Sanofi-Aventis took a significant step forward in its effort to win an FDA approval for Multaq as a therapy for irregular heartbeat. The French company said that the FDA had agreed to give the drug--rejected by the FDA two years ago--a priority review. That should deliver a new verdict on the drug in six months.
Multaq had earned a nonapprovable letter in 2006. The drug is intended to treat atrial fibrillation, a condition that afflicts some 2.5 million Americans. Sanofi has listed Multaq as one of 31 new drugs it intends to win approval for by 2010 as it races to get new products out in the market as blockbuster patents expire.
- read the story [1] from the International Herald Tribune
Related Article:
FDA turns thumbs down on Multaq [2]
Links:
[1] http://www.iht.com/articles/ap/2008/08/08/business/EU-France-Sanofi-Aventis.php
[2] http://www.fiercebiotech.com/story/fda-turns-thumbs-down-on-multaq/2006-09-01