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Medicine / Clinical research / Pharmaceutical industry / Food and Drug Administration / New Drug Application / Structured Product Labeling / Pharmacovigilance / Pharmaceutical sciences / Drug safety / Pharmacology


Iclusig® (ponatinib) 15 mg and 45 mg tablets for oral use.
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Document Date: 2013-12-20 09:46:57

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File Size: 157,91 KB

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City

Philadelphia / Cambridge / Reference / /

Company

Microsoft / REMS APPROVAL ARIAD Pharmaceuticals / /

Country

United States / /

Event

FDA Phase / Man-Made Disaster / /

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IndustryTerm

proposed introductory advertising / drug product / supplemental applications / healthcare / healthcare providers / /

MedicalCondition

T315I-positive chronic myeloid leukemia / positive acute lymphoblastic leukemia / peripheral vascular disease / Newly Diagnosed Chronic Myeloid Leukemia / blast phase / stroke / thromboembolism / blood clots / myocardial infarction / chronic phase / chronic phase CML / chronic myeloid leukemia / MS / ischemic necrosis / /

MedicalTreatment

alternative therapy / /

Organization

Hematology Products office of Hematology / Food and Drug Administration / Research office of Prescription Drug Promotion / office of Prescription Drug Promotion / Food and Drug Administration Center for Drug Evaluation / DEPARTMENT OF HEALTH AND HUMAN SERVICES / Hematology and Oncology Products Center for Drug Evaluation / /

Person

Silver Spring / Andrew Slugg / ANN T FARRELL / Diane Hanner / Ann T. Farrell / /

/

Position

Director / Regulatory Affairs / Regulatory Project Manager / Director Division / M.D. Director Division / /

Product

NEW SUPPLEMENT / S-007 / AP24534 / AP24534-10 / S-008 / generic drug / REMS ASSESSMENT NEW SUPPLEMENT / Ponatinib / new / AP24534-12 / /

ProvinceOrState

Maryland / Massachusetts / /

Technology

pdf / /

URL

http /

SocialTag