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Organofluorides / Nucleosides / Pentostatin / Food and Drug Administration / Hairy cell leukemia / Fludarabine / TNF inhibitor / Leukemia / Medicine / Pharmacology / Pharmaceutical sciences


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857
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City

Dublin / Beltsville / Rockville / /

Company

Ph.D. SuperGen Incorporated / SuperGen Incorporated / D. / /

Event

FDA Phase / Product Issues / /

/

MedicalCondition

fatal pulmonary toxicity / Headache / Leukopenia / Chills / neutropenia / Nausea / thrombocytopenia / refractory chronic lymphocytic leukemia using Nipent / Fever / seizure / Vomiting / active disease / Fatigue / pulmonary edema / Infection / infections / Rash / both untreated and alpha-interferon-refractory hairy cell leukemia / Anemia / hypotension / clinically significant anemia / /

MedicalTreatment

bone marrow transplant / /

Organization

Food and Drug Administration / Division of Drug Marketing / Advertising / and Communications / SuperGen Incorporated NDA / Center for Drug Evaluation and Research / DEPARTMENT OF HEALTH / /

Person

Thomas W. Abrams / James Manuso / /

Position

Director / Chairman / President / and Chief Executive Officer / Ph. Chairman / President / and Chief Executive Officer / /

Product

etoposide / cladribine / cyclophosphamide / Nipent / LEUSTATIN / fludarabine phosphate / responses1 SuperGen / adenosine / pentostatin / Federal Food / rna synthesis / /

ProvinceOrState

Maryland / California / /

Technology

alpha / DNA synthesis / stem cells / apoptosis / /

URL

www.supergen.com / /

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