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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MARYLAND
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` Civil Action No. 8:18-cv-883-DLB
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`AMERICAN ACADEMY OF
`PEDIATRICS, et al.,
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` Plaintiffs,
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` v.
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`UNITED STATES FOOD AND DRUG
`ADMINISTRATION, et al.,
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` Defendants.
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`STATUS REPORT
`In accordance with the Court’s revised remedial order (ECF No. 202), Defendants
`respectfully report as follows:
`Covered Applications: This report includes information about “Covered
`1.
`Applications” as defined in Paragraph 7 of the Court’s revised remedial order. The FDA has used
`the same method for determining which applications constitute Covered Applications as it did in
`its most recent status report (ECF No. 218). Before filing this status report, Defendants conferred
`with Plaintiffs, who agreed that the set of brands covered by paragraph 7 of the revised remedial
`order is the same as in that status report.
`Overall Progress: The FDA remains committed to completing review of the
`2.
`applications it has received as soon as feasible to protect and promote the public health. As
`projected in Defendants’ most recent status report, the FDA took action on 94% of Covered
`Applications by March 31, 2024. The FDA’s best forecast based on current information continues
`to be that it will take action on all remaining Covered Applications by June 30, 2024, as explained
`in Defendants’ most recent status report.
`3.
`In accordance with the Court’s revised remedial order, ECF No. 202, the FDA will
`file another status report on or before July 22, 2024.
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`Case 8:18-cv-00883-DLB Document 220 Filed 04/19/24 Page 2 of 2
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`DATE: April 19, 2024
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`Respectfully submitted,
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`Of counsel:
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`SAMUEL R. BAGENSTOS
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`General Counsel
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`U.S. Dep’t of Health and Human Services
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`MARK RAZA
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`Chief Counsel
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`United States Food and Drug Administration
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`WENDY S. VICENTE
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`Deputy Chief Counsel for Litigation
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`JULIE B. LOVAS
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`Senior Counsel
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`Office of the Chief Counsel
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`Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993-0002
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`BRIAN D. NETTER
`Deputy Assistant Attorney General
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`ERIC B. BECKENHAUER
`Assistant Branch Director
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`/s/ Stephen M. Pezzi
`STEPHEN M. PEZZI
`Senior Trial Counsel
`United States Department of Justice
`Civil Division, Federal Programs Branch
`11000 L Street NW
`Washington, DC 20005
`Tel: (202) 305-8576
`Email: stephen.pezzi@usdoj.gov
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` Counsel for Defendants
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`2
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