Sanofi-Aventis on June 29th temporarily ended its effort to get diet drug rimonabant (Acomplia / Zimulti) approved for sale in the United States, withdrawing its application rather than await next month's near-certain rejection by the U.S. Food and Drug Administration.

The action came less than two weeks after the FDA's expert advisory committee unanimously recommended that sale of rimonabant not be permitted in the United States pending further study of rimonabant's link to an increased risk of depression and suicidality.

Sanofi, in a statement, said it would "undertake the necessary discussions with the FDA to determine" what additional data is needed before resubmitting its application, which will likely not occur until 2010.

But, the company added, "Sanofi-Aventis is committed to making all efforts necessary to make rimonabant available to patients in the U.S. market."

Rimonabant, the first weight-loss drug which works by blocking CB-1 receptors in the brain, has been on sale in Europe for more than a year and currently is approved for sale in 42 countries. Sanofi Senior Vice President Jean-Pierre Lehner said Acomplia is now being taken by more than 200,000 patients.

European Union regulators said a week ago following the FDA advisory panel decision that they will review the medicine for psychiatric side effects, and said today they are "currently reviewing the available data on psychiatric events (in particular suicidal ideation and depression-related events).

"The review is expected to be finalised at the July meeting and its outcome will be communicated then," the European Medicines Agency added.