Food and Drug
Nonprescription Drugs Advisory Committee
Endocrinologic and Metabolic Drugs Advisory Committee
January 23, 2006
The committees will consider the safety and efficacy of newdrug application (NDA) 21-887, proposing
over-the-counter (OTC) use of ORLISTAT (tetrahydrolipstatin) capsules (60 milligrams (mg)),
GlaxoSmithKline Consumer Healthcare, L.P., to promote weight loss in overweight adults when used along with a reduced calorie and low fat diet.
Consumer Health Care, L.P.
statements contained in this document(s) are those of the
product's sponsor, not FDA, and FDA does not
necessarily agree with the sponsor's statements. FDA has
not made a final determination about the safety or
the product described in this document.
Orlistat 60mg Capsules Briefing Document
Portions of this document have
been determined to be exempt from disclosure under the Freedom
of Information Act
(the FOIA) (5 U.S.C. §552).
These redacted portions will appear as white space
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