Camurus announces FDA acceptance of NDA resubmission for Oclaiz (octreotide) for the treatment of acromegaly

Camurus announced that the FDA has accepted for review the company’s resubmission of the New Drug Application (NDA) for Oclaiz (CAM 2029), octreotide extended-release injection, for the treatment of patients with acromegaly. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 10 June 2026.

The application is supported by data from seven clinical studies, including two Phase III studies in the ACROINNOVA program. The updated NDA was submitted to the FDA on 10 December 2025 following a Complete Response Letter (CRL) earlier issued by the Agency, which solely related to observations during a cGMP inspection at a third-party manufacturer’s facility.

The product received marketing authorization in the EU and UK in 2025 under the product name Oczyesa. The product launch has recently been initiated in the EU.

“We look forward to the continued collaboration with the FDA to make Oclaiz available to patients with acromegaly in the US as soon as possible”, says Fredrik Tiberg, President & CEO, Camurus.