Sanofi pulls diet drug application from FDA
Sanofi withdraws Acomplia application from FDA following rejection from experts over reports of suicidal thoughts.
NEW YORK (CNNMoney.com) -- The French drugmaker Sanofi-Aventis withdrew its FDA application for the diet drug rimonabant on Friday, following a rejection from the agency's experts earlier this month.
"Sanofi-Aventis will work toward submitting the rimonabant file to the FDA at a future date," said the company in a press release, noting that the drug is available in 42 countries outside the U.S. "Sanofi-Aventis is committed to taking all steps necessary to make rimonabant available to patients in the U.S. market."
Rimonabant, also known as Acomplia and Zimulti, was unanimously shot down by advisors for the Food and Drug Administration on June 13 after the agency published documents citing increased risks of depression and suicidal thoughts. But the advisory vote was non-binding and the FDA wasn't scheduled to make a final decision on the drug's review until July 26.