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Evenity FDA Approval History

FDA Approved: Yes (First approved April 9, 2019)
Brand name: Evenity
Generic name: romosozumab-aqqg
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Osteoporosis

Evenity (romosozumab) is an anti-sclerostin monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Development timeline for Evenity

Apr  9, 2019Approval FDA Approves Evenity (romosozumab-aqqg) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk of Fracture
Jan 21, 2019Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For Evenity (romosozumab)
Jul 12, 2018Amgen And UCB Resubmit Biologics License Application (BLA) For Evenity (romosozumab) To The US FDA
Sep 11, 2017Evenity (romosozumab) ARCH Study Results Published In The New England Journal Of Medicine
Jul 16, 2017Amgen and UCB Receive Complete Response Letter from U.S. FDA for Evenity (romosozumab) BLA
Sep 26, 2016Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab
Jul 21, 2016Amgen and UCB Submit Biologics License Application for Romosozumab to the FDA

Further information

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