Avandia was severely restricted in 2010 due to concerns about its impact on the heart.
Regulators announced the highly unusual move in a government notice Friday. The FDA will ask a panel of outside experts to review a new analysis of the key study about Avandia’s heart risks.
A spokeswoman for Glaxo said the drug company commissioned researchers at Duke University to reanalyze the study, and submitted the results to the FDA last year.
The FDA first approved the drug in 1999 and it became the top-selling diabetes pill in the world by 2006. Sales began plummeting in 2007 after researchers began questioning the drug’s safety.
Source: Associated Press