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Antiviral Drugs Advisory
September 5, 2007
Merck & Co., Inc.
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
ISENTRESS™ (raltegravir) 400
mg (NDA 22-145), Briefing Document (pdf)
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
FDA Briefing Document (pdf)