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Chemistry / Aripiprazole / Lactams / Quinolones / Otsuka Pharmaceutical / New Drug Application / Pharmaceutical industry / Orphan Drug Act / Orally disintegrating tablet / Food and Drug Administration / Pharmaceutical sciences / Pharmacology


IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND Otsuka Pharmaceutical Co., Ltd., 2-9 Kanda Tsukasa-machi Chiyoda-Ku Tokyo, [removed], Japan, and
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Document Date: 2015-03-25 12:51:00


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File Size: 182,51 KB

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City

Silver Spring / Tokyo / Washington / DC / Washington / D.C. / Carnegie Center Princeton / Center Princeton / /

Company

Otsuka Pharmaceutical Development & Commercialization Inc. / Plaintiff Otsuka America Pharmaceutical Inc. / COMPLAINT Plaintiffs Otsuka Pharmaceutical Co. Ltd. / Plaintiff Otsuka Pharmaceutical Development & Commercialization Inc. / Defendant FDA / Otsuka Pharmaceutical Co. Ltd. / Plaintiff Otsuka Pharmaceutical Co. Ltd. / Chiyoda / Otsuka America Pharmaceutical Inc. / /

Country

Japan / United States / /

Event

FDA Phase / Judicial Event / /

Facility

Center Princeton / /

IndustryTerm

abbreviated new drug applications / federal law / treatment of Tourette’s Disorder / treatment of rare diseases / /

MedicalCondition

rare diseases / Tourette’s Disorder / orphan disorder / diseases / disorders / /

Organization

U.S. Department of Health and Human Services / United States Government / Congress / U.S. Department of Justice / U.S. Food and Drug Administration / UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND Otsuka Pharmaceutical Co. / FDA’s Center for Drug Evaluation and Research / /

Person

Steven F. Osborne / Margaret Hamburg / Stephen Ostroff / Rod J. Rosenstein / Sylvia Mathews Burwell / Mary E. Kremzner / /

Position

Attorney / Secretary / Jr. Attorney General / Defendant HHS Secretary / Commissioner /Acting Commissioner / Commissioner / Acting Commissioner / /

Product

Abilify / such drug / Abilify® / brand drug / New Drug / Food / /

ProgrammingLanguage

DC / /

ProvinceOrState

New Jersey / Maryland / /

URL

http /

SocialTag