Posted by Michael Wonder on 14 Jun 2026
Camurus provides regulatory update on the US NDA for CAM2029 (Oclaiz) in acromegaly
10 June 2026 - Camurus today announced that the US FDA has issued a complete response letter regarding the new drug application for CAM2029 (Oclaiz), octreotide extended release injection, for the treatment of patients with acromegaly.
The complete response letter relates to the observations from the September 2024 cGMP inspection at a third-party manufacturer. The FDA has indicated that satisfactory resolution of these observations, which could include a reinspection of the facility, is required before the NDA can be approved. The FDA also recommends a labeling change to the oxygen absorber component of the product packaging. The complete response letter does not relate to the clinical efficacy or safety of CAM2029.
