Food and Drug
Administration
Joint meeting
of the
Nonprescription Drugs Advisory Committee
and the
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.
Briefing
Information
GlaxoSmithKline
Consumer Health Care, L.P.
Disclaimer
The
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
effectiveness of
the product described in this document.
Orlistat 60mg Capsules Briefing Document
FDA
Disclaimer
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
on the screen or on the printed page.
FDA Backgrounder Table of Contents