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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)

Page last updated October 2, 2006 kkhorizonal rule
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