Up |
AC Home Page
Food and
Drug Administration
Joint Meeting
of the Endocrinologic and Metabolic Drugs Advisory Committee
and the Pharmaceutical Sciences Advisory Committee
October
4, 2006
Briefing
Information
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.
Executive Summary of Questions for Discussion (pdf)
Regulatory History (pdf)
Clinical Background (pdf)
Stability Background (pdf)
Data Tables:
Brand A (pdf)
Brand B (pdf)
Brand C (pdf)
Brand D (pdf)
Brand E (pdf)
Brand F (pdf)
Brand G (pdf)
ERRATA to the FDA Background Package (pdf)
Industry Materials
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.
Genpharm Inc. (pdf)
Mylan Pharmaceuticals Inc.(pdf)