When Sanofi-Aventis SA reported data on a new obesity pill at a medical conference in March 2004, it generated instant buzz.

Hundreds of newspaper and television reports around the world the next day referred to the drug, Acomplia , as a "super pill" and a "miracle drug." With a new approach to obesity, Acomplia promised not only to help people shed pounds but also to raise good cholesterol and cut diabetes risk. It even showed signs of working as an antismoking aid.

"That is amazing. People are going to want this drug today, I'm sure," effused an anchor on ABC's "Good Morning America."

Three years later, Acomplia is looking less like a miracle. The drug still hasn't hit the market in the U.S. The Food and Drug Administration has asked for more data and repeatedly put off approval for the drug as an obesity treatment, while rejecting it for smoking cessation. Side effects associated with Acomplia - including depression and anxiety - are likely giving the FDA particular cause for concern, analysts and doctors say.

Sanofi announced this week that the FDA has scheduled a meeting of its outside advisers on June 13 to review Acomplia's safety and efficacy. That could be a precursor to a final decision.

Acomplia faces trouble in Europe, too. European regulators approved it for sale last summer, but Germany's state-financed health-care system thinks the drug has few real medical benefits and is refusing to pay for it. Other countries, including France, are covering the drug only for limited groups such as people with diabetes.

Success with Acomplia is important for Paris-based Sanofi, whose 2006 sales of about $38 billion make it the world's third-largest drug maker, behind Pfizer Inc. and GlaxoSmithKline PLC. Several of Sanofi's biggest drugs are facing future generic competition, including anticlotting agent Plavix, which Sanofi jointly sells with Bristol-Myers Squibb Co. Recently there has been talk that Sanofi, which completed a hostile takeover of French-German drug maker Aventis in 2004, might be interested in acquiring Bristol-Myers. The companies declined to comment.

The Acomplia troubles show the challenge companies face in pitching potential hit drugs, especially in markets like obesity where public enthusiasm is apt to jump out ahead of the scientific data and regulators' review. Sanofi initially did little to hold back the hype and even contributed to it by distributing a news release at the March 2004 meeting quoting doctors speaking positively about Acomplia. It also said in February of that year that Acomplia "could become a very large blockbuster."

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