Esteve Pharmaceuticals, S.A. – FDA CRL

The FDA issued a Complete Response Letter (CRL) to Esteve Pharmaceuticals, S.A. regarding their New Drug Application (NDA) 213426 for celecoxib and tramadol hydrochloride tablets. A primary reason for non-approval was an inability to complete the inspection of a manufacturing facility, as it was not ready. A satisfactory inspection is a prerequisite for approval, and Esteve must notify the FDA when the facility is prepared.

Additional deficiencies included the proposed Prescribing Information (PI) not conforming to 21 CFR 201.56(a) and (d) and 201.57 content and format regulations. Esteve is required to revise and resubmit the PI and Medication Guide in Structured Product Labeling (SPL) format, ensuring compliance with regulatory standards.

The FDA also determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for the drug, under Section 505-1 of the Federal Food, Drug, and Cosmetic Act, to mitigate risks like addiction, overdose, and death. Further discussions on the REMS will occur after Esteve submits its complete response. Furthermore, Esteve must provide a comprehensive safety update, as specified in 21 CFR 314.50(d)(5)(vi)(b), incorporating all new nonclinical and clinical safety data, detailed changes in the safety profile, updated tabulations, and worldwide experience. The proposed proprietary name, Seglentis, while found acceptable, also requires resubmission with the complete response.