Originally published February 22 2006
FDA panel recommends the approval of weight loss drug Orlistat
by Mike Adams, the Health Ranger, NaturalNews Editor
The non-prescription form of orlistat, a drug already marketed as a prescription drug named Xenical, received a recommendation for approval from an FDA panel.
A Food and Drug Administration panel of doctors and scientists voted Monday to recommend that the regulatory agency approve over-the-counter sales of a weight-loss pill now sold only with a prescription.
Xenical, a fat-blocking obesity drug, was recently voted on by the FDA.
Xenical, a fat-blocking obesity drug, was recently voted on by the FDA.
GlaxoSmithKline Consumer health care still needs final FDA approval before it can sell the non-prescription version of orlistat, a drug already marketed in prescription form as Xenical, to overweight adults as use as a weight-loss aid.
The FDA approved the prescription version of the fat-blocking pill made by Roche in 1999.
XENICAL STRONG RECOMMENDATION: A Food and Drug Administration advisory committee voted 11-3 Monday to recommend the approval of over-the-counter sales of a prescription weight-loss pill.
NEXT STEP: A non-prescription version of GlaxoSmithKline's orlistat, a drug already marketed in prescription form as Xenical, still needs final FDA approval.
NEW RULING: The FDA has never approved any non-prescription weight-loss drugs for sale.
A joint FDA advisory committee voted 11-3 to recommend approval late Monday following a daylong hearing.
The agency usually follows the recommendations of its outside panels of experts.
In six-month clinical trials, obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than did those who were given dummy pills.
Glaxo wants people to use it for only six months at a time, but as an over-the-counter item, its use could not be policed.
However, the pill's effect ends once its use is stopped, said Julie Golden, a medical officer in the FDA's division of metabolism and endocrinology products.
A previous study showed a progressive weight gain in patients after they discontinued use of orlistat, Golden said.
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