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# FDA Issues 2nd Complete Response Letter on Acromegaly Drug
- URL: https://www.fdaweb.com/fda-issues-2nd-complete-response-letter-on-acromegaly-drug/
- Published: 2026-06-11T12:00:00.000Z
- Updated: 2026-09-14T13:40:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161301

FDA has issued a second complete response letter (CRL) to Swedish biotechnology company Camurus regarding its NDA for Oclaiz (octreotide), an extended-release injection under review for the treatment of acromegaly. The agency's decision was tied to manufacturing-related observations identified during a 2024 GMP inspection of a third-party production facility rather than concerns about the drug's efficacy or safety, according to Camurus.

In 2025, the NDA was issued a CRL that was also limited to findings from a GMP inspection at the third-party manufacturing facility.

The agency's current CRL said the inspection findings must be satisfactorily resolved before the application can be approved, a process that could include a reinspection of the manufacturing site. The agency also recommended a labeling modification involving an oxygen absorber component used in the product's packaging, according to the company.

Camurus said the contract manufacturer has implemented corrective and preventive actions to address the inspection observations, provided updates to FDA on remediation efforts, and declared itself ready for a follow-up inspection.

Oclaiz is a long-acting subcutaneous formulation of octreotide designed for monthly self-administration using an autoinjector pen. The product is based on Camurus’ FluidCrystal technology and is intended to provide improved disease control with greater convenience than existing intramuscular depot formulations, the company says.

The NDA is supported by data from seven clinical studies, including two Phase 3 trials conducted as part of the ACROINNOVA program. In those studies, Camurus said the drug demonstrated higher bioavailability than currently approved long-acting intramuscular octreotide and led to improved biochemical control and symptom reduction in patients with acromegaly.

Acromegaly is a rare endocrine disorder caused by excess growth hormone, most often due to a pituitary tumor, and is associated with significant morbidity if not adequately controlled.

Camurus noted that the CRL does not affect the drug’s ongoing development in other indications, including gastroenteropancreatic neuroendocrine tumors and polycystic liver disease.