Monday, October 19, 2009

Amgen Provides Update on Status of Prolia(TM) (Denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration (FDA)

THOUSAND OAKS, Calif. – Oct 19, 2009 – Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia(TM) (denosumab) in the treatment and prevention of postmenopausal osteoporosis. The FDA issues Complete Response Letters to request additional information needed to complete the review of applications for product approval. 

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