rbiogenidec-J~----------------
`
`February 12, 2009
`
`Russell Katz, MD
`Food and Drug Administration
`Center for Drug Evaluation and Research
`5901 -B Ammendale Rd
`Beltsville, MD 20705-1 266
`
`RE: BG00012 (Dimethyl Fumarate): Multiple Sclerosis --IND 73,061
`Information Amendment: Final Nonclinical Study Report
`Serial No. 0081
`
`Dear Dr. Katz:
`
`This submission contains the final report from a 2-year carcinogenicity study in mice
`administered BG00012 (Report No. P00012-05-03), entitled:
`
`"A Two Year Oral (Gavage) Carcinogenicity Study in Mice with BG00012"
`
`Should you require any additional information, please contact Tammy Sarnelli,
`Director, Regulatorr Affairs at 617-679-3513. The contact for technical aspects for this
`, Senior Director, Regulatory Affairs Operations at 61 7-679-
`submission is
`2416.
`
`ior Vice President, Regulatory Affairs
`Phone (61 7) 679-3783
`Fax (617) 679-3170
`
`Page 1oft
`
`Biogeo Exhibit 2284
`Coalition v. Biogeo
`IPR2015-01993
`
`
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