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Radius Reveals Abaloparatide Delay, After Playing Up Launch Readiness

 
• By Emily Hayes

FDA's review of filing for osteoporosis abaloparatide delayed by three months to June 30, bringing it closer to the action date for Amgen's competing anabolic agent romosuzumab, which has an action date of July 19.

Shoulder fracture

Radius Health Inc. announced that FDA has extended the user fee date for its anabolic osteoporosis drug abaloparatide from March 30 to June 30, soon after the company discussed extensive plans for launch with no mention of a regulatory delay.

FDA needs more time to review the NDA for the daily subcutaneous formulation in postmenopausal osteoporosis "to allow time to...

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