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Abraxane Approval History

FDA Approved: Yes (First approved January 7, 2005)
Brand name: Abraxane
Generic name: paclitaxel protein-bound
Dosage form: for Injectable Suspension
Company: American Pharmaceutical Partners, Inc. / American Bioscience, Inc.
Treatment for: Breast Cancer, Non-Small Cell Lung Cancer, Pancreatic Cancer

Abraxane (paclitaxel protein-bound) is an albumin-bound form of the antineoplastic agent paclitaxel indicated for the treatment of breast cancer, non-small cell lung cancer, and pancreatic cancer.

Development History and FDA Approval Process for Abraxane

DateArticle
Mar  8, 2019Approval FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
Sep  6, 2013Approval FDA Approves Abraxane for Late-Stage Pancreatic Cancer
Oct 12, 2012Approval FDA Approves Abraxane for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
Jan  7, 2005Approval Abraxane American Pharmaceutical Partners, Inc. / American Bioscience, Inc. - Treatment for Metastatic Breast Cancer
May 10, 2004American Pharmaceutical Partners and American BioScience Announce FDA Acceptance of New Drug Application of Abraxane for the Treatment of Metastatic Breast Cancer
Mar  8, 2004American Pharmaceutical Partners and American BioScience Announce Filing of a New Drug Application for FDA Approval of Abraxane for the Treatment of Metastatic Breast Cancer

Further information

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