Camurus provides regulatory update on the US NDA for CAM2029 in acromegaly

Camurus

22 October 2024 - The FDA issues a complete response letter for CAM2029 pending FDA’s assessment of responses from a third party manufacturer to observations from a recently completed cGMP inspection.

Camurus today announced that the US FDA has issued a complete response letter regarding the new drug application for CAM2029 (octreotide) extended release injection for the treatment of patients with acromegaly.

Read Camurus press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Dossier