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City Beltsville / Cambridge / Reference / / Company Senior Regulatory Associate Alkermes Inc. / Alkermes Inc. / Nancie A. Zecco Alkermes Inc. / / Event FDA Phase / Product Issues / Product Recall / / / MedicalCondition insomnia/sleep disorder / headache / coagulation disorder / liver failure / acute hepatitis / eosinophilic pneumonia / previously exhibited hypersensitivity / nausea / chronic illness / active liver disease / thrombocytopenia / hepatic injury / vomiting / dose causing hepatic injury / dizziness / muscle cramps / tiredness / liver disease / depression / hepatocellular injury / / MedicalTreatment counseling / / Organization VIVITROL administration / Food and Drug Administration / Division of Drug Marketing / Advertising / and Communications / DOSAGE AND ADMINISTRATION / Center for Drug Evaluation and Research / MPH Regulatory Review officer Division of Drug Marketing / DEPARTMENT OF HEALTH / / Person Silver Spring / Susannah K. Hubert / / Position financial advisor / musician / restaurant worker / / Product naloxone / opiate / Vivitrol / Communication / Vivitrol® / / ProvinceOrState Maryland / Massachusetts / / SocialTag 
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993