The weaker version of the weight loss drug Xenical, called Alli advanced further forward in the regularatory process on April 7th when the directors of the pharmaceutical giant Glaxo Smith Kline released an announcement that the all important 'approvable' notification letter had been recieved from the FDA with regards to Alli.

This letter is a big step forward in the FDA's process for allowing the sale of drugs but does still mean that certain criteria have to met before full approval is given. At present the spokesman for GSK has not revealed the exact contents of the approvable letter and so the extra information that the FDA needs with regard to Alli is not yet available, however they did say that no further tests on overweight people was needed.

The GSK spokesman said that they were taking all the FDA recommendations seriously and would be moving ahead fast to get all the issues covered so that teh drug Alli would be available for sale in the US by the end of 2006. If all goes according to plan Alli will be the first diet pill to be sold over the counter without prescription that actually has an FDA approval.

Most of the testing and research with Alli has previously been done with the approval process for Xenical. All Alli is, is a half strength version of Xenical containing 50% of the active ingredient orlistat found in Xenical. More research therefore was not necessary for Alli especially as Xenical has been sold all over the world for over 6 years without any serious safety problems being noted.

The reason why Xenical hasn't been more widely used and received is partly due to an unpleasant side effect that causes users to experience excessive flatulence and very oily and loose bowel movements due to the fact that the drug prevents the fat in food from getting into the body.

Back in January the FDA panel of experts listened to alot of evidence and arguments regarding orlistat and Xenical and eventually ruled in favour of the approval of Alli by 11 to 3. It was thought that the evidence of the huge number of overweight and obese Americans was a determining factor in its approval and its definite weight loss benefits were undisputed. From a safety point of view some small concerns were voiced about its prolonged use, but not sufficient to prevent is eventual sale.

GSK reckon that Alli would eventually be used by as many as five or six million Americans yearly and would seriously boost the profits of the pharmaceutical group. Many FDA unapproved diet pills which don't need prescription are sold in gyms,health food shops and online and GSK is keen to have Alli marketed as a safe and clinically proven weight loss drug that can be easily bought. GSK will run its promotion of the Alli drug alongside advice and recommendations that good diet and physical exercise are essential to weight loss too.