A year ago at this time, millions of overweight and obese Americans were excitedly awaiting both a new prescription weight-loss drug, rimonabant (Acomplia / Zimulti), and the first over-the-counter diet drug, Alli (low-dose Xenical), which were expected to be on the U.S. market by summer.

But twelve disappointing months later, FDA approval of Acomplia and Alli (pronounced Al-EYE) seems further off now than it seemed last January.

It has now been nine months since the U.S. Food and Drug Administration put a hold on approval of Alli, and observers are starting to wonder if the agency is having second thoughts about making the half-strength version of prescription Xenical (orlistat) the first FDA-approved over-the-counter weight-loss drug.

As for Acomplia, it has been eleven months since the FDA put a hold on the Sanofi-Aventis diet drug, and the earliest that action seems likely to occur is the end of April.

Professions of optimism from Sanofi and GlaxoSmithKline that their products would soon be on the U.S. market also have largely disappeared.

Glaxo, which originally hoped to be putting up displays of Alli in the aisles of pharmacies way back last summer, now is saying nothing about when it hopes to get the diet pill on the market.

The Alli situation is rendered more perplexing by the fact that two FDA advisory committees heard arguments both for and against approving the over-the-counter version of Xenical a year ago, and voted 11-to-3 in favor of non-prescription sale of the drug.

The FDA is not obligated to follow the recommendations of its advisory panels, but it generally does.

No FDA advisory committee meeting, meanwhile, has even been scheduled for Acomplia. Few think that the FDA will act on Acomplia until its Endocrinologic and Metabolic Drugs Advisory Committee weighs in on the issue of the drug's side-effects, and the panel's first meeting of the year is tentatively set for June.

Glaxo had hoped to market Alli as a prescription-quality alternative to unapproved diet supplements sold in health-food stores, drugstores and over the internet, and had said Alli could cost U.S. consumers $12 to $25 a week.

Americans eager to obtain Acomplia, meantime, are in some cases paying more than $200 per month to obtain it from Europe, where it is on sale in half a dozen countries. Acomplia also is expected to be available starting this month in Mexico, but no pricing information has yet been released.