FDA CRL - Bridge Regulatory Affairs, LLC

The FDA issued a Complete Response Letter (CRL) for New Drug Application (NDA) 218600, concerning octreotide hydrochloride extended-release injection, submitted by Bridge Regulatory Affairs, LLC, on behalf of Camurus AB. The agency determined that the application cannot be approved in its current form due to several outstanding deficiencies.

A primary concern involves the manufacturing facility. Following a Current Good Manufacturing Practices (CGMP) inspection, deficiencies were identified. The facility must provide satisfactory responses to the FDA, which may necessitate a re-inspection and a pre-approval inspection (PAI) to ensure compliance. Resolution of these issues is critical for approval.

Further issues relate to product labeling and safety information. The proposed Prescribing Information requires revision to align with prior FDA communications and must adhere to regulatory content and format requirements (21 CFR 201.56(a), (d), and 201.57), including submission in Structured Product Labeling (SPL) format. Similarly, carton and container labeling needs revision. The proprietary name, previously conditionally acceptable, must be resubmitted with the complete response.

A comprehensive safety update is also mandated under 21 CFR 314.50(d)(5)(vi)(b). This update should detail any significant changes in the safety profile, include new clinical data, provide re-tabulations of adverse events, present case reports for serious events, and summarize worldwide safety experience. Camurus AB is required to fully address all deficiencies and resubmit the application within one year to avoid potential withdrawal.