U.S. Food and Drug Administration Center for Drug Evaluation and Research
FDA Oncology Tools Approval Summary for sargramostim for Acceleration of myeloid recovery following autologous bone marrow transplant in patients with non-Hodgkin's lymphoma, acute lymphocytic leukemia, or Hodgkin's disease

Generic Drug Name sargramostim
Trade Name Leukine
Sponsor or Applicant Berlex
Application Number 103362
Supplement Number  
Supplement Type Code  
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General Indication  
Line or type of therapy  
Specific Indication Acceleration of myeloid recovery following autologous bone marrow transplant in patients with non-Hodgkin's lymphoma, acute lymphocytic leukemia, or Hodgkin's disease
Subpart H-Accelerated Approval? 0
Filing Date  
Advisory Committee Date  
Advisory Committee Recommendation  
   
Approval Date Mar 05 1991
Number of Studies Reviewed  
Study Comments  
Study Results  
Study Details (Click on NDA or Supplement Number to view details) NDA 103362 Supplement
Follow Up Commitments