FDA Accepts Camurus NDA Resubmission for Oclaiz in Acromegaly, Sets December 2026 PDUFA Date
The FDA accepted Camurus' NDA resubmission for Oclaiz in acromegaly, setting a December 2026 PDUFA date. The filing follows a June 2026 Complete Response Letter related to third-party manufacturing, with no safety or efficacy issues. Oclaiz is a once-monthly subcutaneous octreotide already approved in the EU as Oczyesa.