FDA CRL - International Medication Systems Ltd.

The Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on December 12, 2018, to International Medication Systems, Limited, regarding its New Drug Application (NDA 211363) for Epinephrine Injection USP. The application, submitted under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, was deemed unapprovable due to several deficiencies. Key issues included product quality concerns, specifically that the proposed drug product formulation was considered suboptimal and unacceptable, failing to meet ICH Guidance Q8 (R2) standards for pharmaceutical development. The FDA also cited quality labeling deficiencies, requiring the replacement of the term "single-use" with "single-dose" throughout the product's label and labeling. Furthermore, the application lacked proper patent certifications for patents 10,004,700 and 10,039,728, which are listed in the Orange Book for the referenced drug (NDA 205029). To address these concerns, International Medication Systems must provide batch analysis and stability data from commercially processed batches. The labeling must be corrected, and a complete patent certification or statement is required. Additionally, the company must submit a comprehensive safety update incorporating all new nonclinical and clinical study data, including detailed analyses of adverse events and updated exposure information. The applicant has one year to resubmit the application, fully addressing all outstanding deficiencies.