A: A multivitamin
should be taken
every day when
Alli (Orlistat) is
used as part of a
weight loss
program.
http://www.fda.gov/cder/drug/infopage
/orlistat_otc/index.htm
should be taken
every day when
Alli (Orlistat) is
used as part of a
weight loss
program.
http://www.fda.gov/cder/drug/infopage
/orlistat_otc/index.htm
FDA Joint Advisory Committee recommends approval of orlistat 60 MG capsules
for over-the-counter use
Orlistat the only FDA-approved weight-loss treatment available over-the-counter
U.S. Food and Drug Administration’s (FDA) joint Nonprescription Drugs and
Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 to recommend
approval of orlistat 60 mg capsules for over-the-counter (OTC) use in the United States.
OTC orlistat, which GSK proposes to market under the brand name Alli ™ (pronounced
AL-eye), would be the only FDA-approved weight loss medication available over-the-
counter.
Alli would be indicated for use by overweight adults along 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. “We look forward to working with the FDA to gain final approval.”
“We are excited by the potential opportunity to provide consumers with an FDA-
approved over-the-counter option that 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.
Unique among weight loss medications, orlistat is non-systemic. It does not
affect the central nervous system, and has no effect on the heart or the brain.
Orlistat is a weight-loss medication that is taken with meals to inhibit the absorption of
dietary fat.
Orlistat should be used in conjunction with a reduced calorie diet that contains no more
than 30 percent of calories from fat.
Following such a diet maximizes weight loss and minimizes unwanted gastrointestinal
treatment effects. Help and advice on adopting a healthy eating plan will be provided in
the Alli program.
The safety and efficacy of orlistat, which has been marketed as a prescription drug in the
U.S. since 1999, is supported by more than 100 clinical studies conducted in more than
30 countries, including the four-year landmark XENDOS trial, the longest study ever of a
weight loss medicine. More than 22 million people in 145 countries have used orlistat.
Xenical® (orlistat 120 mg capsules) will remain available by prescription for obesity
management and for those who should be treated under the care of a physician.
Xenical is manufactured by Roche and co-promoted in the U.S. by GlaxoSmithKline
Consumer Healthcare.
http://www.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=725
for over-the-counter use
Orlistat the only FDA-approved weight-loss treatment available over-the-counter
U.S. Food and Drug Administration’s (FDA) joint Nonprescription Drugs and
Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 to recommend
approval of orlistat 60 mg capsules for over-the-counter (OTC) use in the United States.
OTC orlistat, which GSK proposes to market under the brand name Alli ™ (pronounced
AL-eye), would be the only FDA-approved weight loss medication available over-the-
counter.
Alli would be indicated for use by overweight adults along 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. “We look forward to working with the FDA to gain final approval.”
“We are excited by the potential opportunity to provide consumers with an FDA-
approved over-the-counter option that 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.
Unique among weight loss medications, orlistat is non-systemic. It does not
affect the central nervous system, and has no effect on the heart or the brain.
Orlistat is a weight-loss medication that is taken with meals to inhibit the absorption of
dietary fat.
Orlistat should be used in conjunction with a reduced calorie diet that contains no more
than 30 percent of calories from fat.
Following such a diet maximizes weight loss and minimizes unwanted gastrointestinal
treatment effects. Help and advice on adopting a healthy eating plan will be provided in
the Alli program.
The safety and efficacy of orlistat, which has been marketed as a prescription drug in the
U.S. since 1999, is supported by more than 100 clinical studies conducted in more than
30 countries, including the four-year landmark XENDOS trial, the longest study ever of a
weight loss medicine. More than 22 million people in 145 countries have used orlistat.
Xenical® (orlistat 120 mg capsules) will remain available by prescription for obesity
management and for those who should be treated under the care of a physician.
Xenical is manufactured by Roche and co-promoted in the U.S. by GlaxoSmithKline
Consumer Healthcare.
http://www.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=725
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