> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Accepts Camurus’ NDA Resubmission for Acromegaly Drug
- URL: https://www.fdaweb.com/fda-accepts-camurus-nda-resubmission-for-acromegaly-drug/
- Published: 2026-01-09T12:00:00.000Z
- Updated: 2026-09-14T15:30:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160465

FDA has accepted for review a Camurus NDA resubmission for Oclaiz (octreotide), a once-monthly treatment for acromegaly. The agency assigned a 6/10 user fee review action target date.

Camurus says it resubmitted the NDA on 12/10 after receiving earlier in the year a complete response letter that was limited to findings from a current good manufacturing practice inspection at a third-party manufacturing facility. The company says the deficiencies cited in the CRL did not relate to clinical efficacy or safety.

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 says 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.