Xenical Medication Orlistat May Become OTC Weight Loss Pill
Updated February 15, 2014.
Orlistat, a weight loss medication previously only available via prescription in the drug called Xenical, may soon become available over-the-counter.
GlaxoSmithKline Consumer Healthcare has announced that an FDA committee voted 11 to 3 to recommend approval of orlistat 60 mg capsules for OTC use in the US. OTC orlistat, which GSK plans to call Alli, would be used by overweight adults in conjunction with a reduced calorie, low-fat diet.
“We are encouraged by the Committee’s recommendation for approval of what would be the only FDA-approved safe and effective OTC weight-loss aid for overweight adults,” said George Quesnelle, President, GlaxoSmithKline Consumer Healthcare North America, in a news release.
“[Orlistat] promotes gradual yet meaningful weight loss. Alli will be more than a pill; it will be a program that will help people lose weight, adopt a healthy eating plan and make other lifestyle changes,” added Quesnelle.
Orlistat does not have any affect on the central nervous system, heart or brain. Orlistat inhibits the absorption of some of the dietary fat that is consumed in the diet. It is to be taken with reduced-calorie meals containing no more more than 30 percent of calories from fat (Following the recommended diet prevents unwanted GI side effects, according to the makers.).
Orlistat has been available as a prescription drug in the U.S. since 1999. According to GlaxoSmithKline: Clinical studies for the drug have been conducted in more than 30 countries, including the XENDOS trial, the longest study ever of a weight loss medicine; more than 22 million people in 145 countries have used orlistat.
Xenical (which contains twice as much orlistat as the proposed OTC version) will be only available by prescription for obese individuals under the care of a physician.
Source:
GlaxoSmithKline News Release: GSK.com --FDA Joint Advisory Committee recommends approval of orlistat 60 MG capsules for over-the-counter use
Article Created: January 24, 2006
Last Updated: January 25, 2006
Orlistat, a weight loss medication previously only available via prescription in the drug called Xenical, may soon become available over-the-counter.
GlaxoSmithKline Consumer Healthcare has announced that an FDA committee voted 11 to 3 to recommend approval of orlistat 60 mg capsules for OTC use in the US. OTC orlistat, which GSK plans to call Alli, would be used by overweight adults in conjunction with a reduced calorie, low-fat diet.
“We are encouraged by the Committee’s recommendation for approval of what would be the only FDA-approved safe and effective OTC weight-loss aid for overweight adults,” said George Quesnelle, President, GlaxoSmithKline Consumer Healthcare North America, in a news release.
“[Orlistat] promotes gradual yet meaningful weight loss. Alli will be more than a pill; it will be a program that will help people lose weight, adopt a healthy eating plan and make other lifestyle changes,” added Quesnelle.
Orlistat does not have any affect on the central nervous system, heart or brain. Orlistat inhibits the absorption of some of the dietary fat that is consumed in the diet. It is to be taken with reduced-calorie meals containing no more more than 30 percent of calories from fat (Following the recommended diet prevents unwanted GI side effects, according to the makers.).
Orlistat has been available as a prescription drug in the U.S. since 1999. According to GlaxoSmithKline: Clinical studies for the drug have been conducted in more than 30 countries, including the XENDOS trial, the longest study ever of a weight loss medicine; more than 22 million people in 145 countries have used orlistat.
Xenical (which contains twice as much orlistat as the proposed OTC version) will be only available by prescription for obese individuals under the care of a physician.
Source:
GlaxoSmithKline News Release: GSK.com --FDA Joint Advisory Committee recommends approval of orlistat 60 MG capsules for over-the-counter use
Article Created: January 24, 2006
Last Updated: January 25, 2006
