Swedish biopharmaceutical company Camurus AB (STO:CAMX) reported on Tuesday that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide) extended-release injection for the treatment of patients with acromegaly.

The CRL is due to facility-related deficiencies identified during a recent cGMP inspection of a third-party manufacturer.

Camurus said that it is committed to working with the FDA and the manufacturer to address the outstanding observations and secure approval for CAM2029. The CRL does not impact other development programmes for CAM2029.