Approval Summary: Letrozole (Femara® Tablets) for Adjuvant and Extended Adjuvant Postmenopausal Breast Cancer Treatment: Conversion of Accelerated to Full Approval

On April 30, 2010, the U.S. Food and Drug Administration converted letrozole (Femara®; Novartis Pharmaceuticals Corporation, East Hanover, NJ) from accelerated to full approval for adjuvant and extended adjuvant (following 5 years of tamoxifen) treatment of postmenopausal women with hormone receptor...

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Autores principales: Cohen, Martin H., Johnson, John R., Justice, Robert, Pazdur, Richard
Formato: Artigo
Lenguaje:Inglês
Publicado: AlphaMed Press 2011
Materias:
Regulatory Issues: FDA
Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC3248775/
https://ncbi.nlm.nih.gov/pubmed/22089970
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2011-0287
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