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Kepivance Approval History

FDA Approved: Yes (First approved December 15, 2004)
Brand name: Kepivance
Generic name: palifermin
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Mucositis

Kepivance (palifermin) is a recombinant human keratinocyte growth factor indicated to decrease the incidence and duration of severe oral mucositis.

Development History and FDA Approval Process for Kepivance

DateArticle
Dec 15, 2004Approval Kepivance Amgen Inc. - Treatment for Severe Oral Mucositis in Cancer Patients
Jun 24, 2004Amgen Submits Biologics License Application for FDA Approval of Palifermin

Further information

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