UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
____________________________________
MYLAN LABORATORIES, INC., et al.,
)
)
Plaintiffs,
)
)
v.
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Civil Action No. 07-0579 (RMU)
)
MICHAEL O. LEAVITT, Secretary,
)
Health and Human Services, et. al.,
)
)
Defendants.
)
)
AND
)
)
TEVA PHARMACEUTICALS USA,
)
INC.,
)
)
APOTEX INC.,
)
)
MUTUAL PHARMACEUTICAL
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CO., INC.,
)
)
Intervenors.
)
____________________________________)
NOTICE OF FILING FDA DECISION
The government defendants, Michael O. Leavitt, Secretary of Health and Human
Services, Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs, and the Food
and Drug Administration (FDA), hereby submit, pursuant to the Court’s Order of April 10, 2007,
their decision regarding the approval of applications for generic versions of amlodipine besylate
tablets. The Court’s April 10 Order further directed FDA to respond to Mylan’s TRO by 9:00
a.m. April 19 “[i]f the FDA decides to grant the ANDAs.” As reflected in the attached decision,
FDA has decided not to approve ANDAs other than Mylan’s at this time. For this reason, the
briefing contemplated in the Court’s April 10 Order is not appropriate. The government
Case 1:07-cv-00579-RMU Document 40 Filed 04/18/2007 Page 1 of 2
2
defendants suggest that it may be appropriate to schedule a status conference regarding the next
steps to be taken in this litigation.
Of Counsel:
Respectfully submitted,
DANIEL MERON
PETER D. KEISLER
General Counsel
Assistant Attorney General
SHELDON T. BRADSHAW
EUGENE M. THIROLF
Associate General Counsel
Director
Food and Drug Division
ERIC M. BLUMBERG
Deputy Chief Counsel, Litigation
/s/
DRAKE CUTINI
KAREN E. SCHIFTER
Attorney
Associate Chief Counsel, Litigation
Office of Consumer Litigation
U.S. Dept. of Health & Human Services
U.S. Department of Justice
Office of the General Counsel
P.O. Box 386
5600 Fishers Lane
Washington, D.C. 20044
Rockville, MD 20857
Tel: 202-307-0044
301-827