Pharma powerhouse Camurus has announced today that the US FDA has accepted for review its resubmitted New Drug Application (NDA) for Oclaiz, an octreotide extended-release injection for patients with acromegaly. 

 

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026.

 

“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,” said Fredrik Tiberg, President & CEO of Camurus.

 

Oclaiz is a once-monthly, subcutaneous long-acting octreotide depot designed for optimized disease control and convenient self-administration via an autoinjector pen. The therapy is built on Camurus’ FluidCrystal technology and is backed by seven clinical studies, including two Phase 3 trials from the ACROINNOVA program.

 

The NDA resubmission, filed on December 10, 2025, follows a Complete Response Letter (CRL) issued by the FDA earlier, which cited only observations from a cGMP inspection at a third-party manufacturer.