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news.Ipsen has received the US Food and Drug Administration (FDA) approval for its Prior Approval Supplement application for the extended dosing Interval of Somatuline Depot for patients suffering from acromegaly.
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The extended dose interval of Somatuline Depot 120mg of 6 to 8 weeks is expected to offer patients with acromegaly who are currently controlled on Somatuline Depot 60mg or 90mg every 4 weeks, a possibility to reduce the number of injections per year.
Ispen said the approval revises the US Package Insert to allow acromegalic patient to be treated on an extended dosing interval for up to 8 weeks.
Ipsen Corporate Development executive vice-president Stephane Thiroloix said this new approval confirms Ipsen’s positioning as a patient-centric organization and reaffirms the Group’s commitment to innovation for patient care.
"The Group will aggressively pursue its life cycle management strategy to maximize the potential of Somatuline Depot and to reinforce its status of key growth driver in the coming years," Thiroloix said.