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FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia.
Krauss, Aviva C; Gao, Xin; Li, Liang; Manning, Michael L; Patel, Paresma; Fu, Wentao; Janoria, Kumar G; Gieser, Gerlie; Bateman, David A; Przepiorka, Donna; Shen, Yuan Li; Shord, Stacy S; Sheth, Christopher M; Banerjee, Anamitro; Liu, Jiang; Goldberg, Kirsten B; Farrell, Ann T; Blumenthal, Gideon M; Pazdur, Richard.
Affiliation
  • Krauss AC; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. aviva.krauss@fda.hhs.gov.
  • Gao X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Li L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Manning ML; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Patel P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Fu W; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Janoria KG; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gieser G; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Bateman DA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Przepiorka D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Shen YL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Shord SS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Sheth CM; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Banerjee A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Liu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Goldberg KB; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Farrell AT; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Blumenthal GM; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 25(9): 2685-2690, 2019 05 01.
Article in En | MEDLINE | ID: mdl-30541745
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Leukemia, Myeloid, Acute / Antineoplastic Combined Chemotherapy Protocols / Drug Approval / Liposomes Type of study: Clinical_trials / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: America do norte Language: En Journal: Clin Cancer Res Year: 2019 Document type: Article
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Leukemia, Myeloid, Acute / Antineoplastic Combined Chemotherapy Protocols / Drug Approval / Liposomes Type of study: Clinical_trials / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: America do norte Language: En Journal: Clin Cancer Res Year: 2019 Document type: Article