Weight Loss Drugs - weight loss information

The new weight loss drug Alli is about to hit the U.S. market.

Alli which is produced by GlaxoSmithKline will be available to consumers in America next week following a 150 million dollar advertising campaign to promote the non-prescription drug.

Alli will be the only non-prescription drug marketed as a weight loss remedy that has the approval of the Food and Drug Administration.

The drug works by reducing the amount of fat that is absorbed by the body; the undigested fat is eliminated in bowel movements, which can cause side effects such as gas and oily discharge.

Alli is a half-dose version of the Roche prescription drug Xenical which also works by reducing the amount of fat the body absorbs from food.

It will cost between $55 and $60 for a month's supply, just over 60 cents per tablet, based on a regimen of three pills a day.

Alli is good news for GSK who are still recovering from the safety scare over it's diabetes drug Avandia.

GSK hopes the product will be available in Europe, under a different name, in 2008 and are also planning to submit Alli for regulatory approval in Canada, Latin America, China, Australia and New Zealand before the end of 2007.

Glaxo is stressing in their advertisements that Alli is no "magic bullet" and requires commitment to a low-fat diet.

It will compete with multiple OTC supplements that claim weight-loss benefits but have not been cleared by the FDA.

Source: http://www.news-medical.net/?id=26221

How is it possible that mid-sized Indian pharmaceutical companies are already selling their own versions of diet drug rimonabant in India while the original developer of the drug, Sanofi-Aventis, still doesn't have Indian government approval to sell Acomplia?

Well, part of the answer may be that Sanofi was so focused on getting approval to sell the drug in Europe (where Acomplia went on sale last summer) and in the United States (where it still awaits regulatory action) that the French pharmaceutical giant was late in filing for marketing authorization in India.

While a Sanofi spokesperson said the company filed last summer with India's Central Drugs Standard Control Organization, which regulates the market authorization of new drugs as well as the standards for imported drugs, Sanofi confirmed that the Indian regulatory agency has not yet acted on Acomplia.

"It's too soon to tell what will be our strategy regarding the launch of Acomplia in India,'' a Sanofi spokesperson told Bloomberg News last week.

Given the relatively high cost of the drug -- generally somewhat more than US$100 per month -- in the dozen plus countries where Acomplia is already on sale, Sanofi may have thought the number of Indians who would be able to afford a price of this magnitude would be relatively small.

But in the meantime, Indian pharmaceutical companies that seem to have replicated Sanofi's version of the rimonabant molecule -- which apparently was never granted patent protection in India -- independently filed with the regulatory agency and received approval to sell their own versions of the drug.

With at least two companies -- Torrent Pharmaceuticals and Zydus Cadila -- already selling Rimoslim and Slimona in India for under US$6 per month, the market for rimonabant in a country that has a growing urban, middle-class obesity problem may turn out to be significantly greater than Sanofi believed.

Source: http://www.dietdrugreport.com/News/news-052707.htm

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

Read the rest of this entry ... (218 words left)