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Fertility medicine / Histrelin / Gonadotropin-releasing hormone agonist / Gonadotropin-releasing hormone / Food and Drug Administration / Prostate cancer / Testosterone / Degarelix / Triptorelin / Endocrine system / GnRH agonists / Medicine


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993
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City

Beltsville / MSPAS / Reference / Chadds Ford / /

Company

Mark Klinger Endo Pharmaceuticals Inc. / Regulatory Affairs Endo Pharmaceuticals Inc. / Endo Pharmaceuticals Inc. / /

Event

FDA Phase / /

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IndustryTerm

treatment of advanced prostate cancer / therapy for prostate cancer / /

MedicalCondition

ureteral obstruction / paralysis / advanced prostate cancer / sudden cardiac death / hyperglycemia / stroke / fatigue / myocardial infarction / diabetes mellitus / spinal cord compression / hypersensitivity / anaphylactic reactions / prostate cancer / /

MedicalTreatment

Hormone therapies / /

Organization

Division of Consumer Drug Promotion / Food and Drug Administration / U.S. Food and Drug Administration / Division of Drug Marketing / Advertising / and Communications / office of Prescription Drug Promotion / Division of Consumer Drug Promotion office of Prescription Drug Promotion / Center for Drug Evaluation and Research / DEPARTMENT OF HEALTH / Consumer Drug Promotion Office / Division of Professional Drug Promotion / /

Person

MICHELLE L SAFARIK / Silver Spring / Amy Toscano / Michelle Safarik / /

Position

CPA Team Leader Division / Director / PA-C Regulatory Review Officer / /

Product

testosterone / VANTAS / VANTAS® (histrelin acetate) / /

ProvinceOrState

Pennsylvania / Maryland / /

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