FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

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Summary

FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen. This action approves changes to PROLIA's labeling/indications.

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Diseases / indications

• Glucocorticoid-induced Osteoporosis
• Osteoporosis in Men
• Postmenopausal Osteoporosis

Drugs mentioned

• Prolia (denosumab)

Snippet

SUPPL AP for PROLIA (DENOSUMAB)