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Kepivance FDA 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 timeline 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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