FDA CRL - Zhejiang Novus Pharmaceuticals Co. Ltd

The FDA issued a Complete Response Letter (CRL) to Zhejiang Novus Pharmaceuticals Co. Ltd. on June 15, 2018, regarding its New Drug Application (NDA 210274) for Vancomycin Hydrochloride for Injection. The application, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, could not be approved due to several deficiencies. Key issues include concerns related to Product Quality and Prescribing Information. The proposed labeling needs revision to conform with regulatory format requirements and must be submitted in Structured Product Labeling (SPL) format.

A significant portion of the CRL outlines extensive requirements for an updated Safety section. The company must provide a comprehensive safety update, incorporating new data from all nonclinical and clinical studies. This includes detailing significant changes in the safety profile, presenting retabulations of adverse events and reasons for trial discontinuations, and submitting case report forms and narrative summaries for serious adverse events and patient deaths. Updated exposure information and a summary of worldwide safety experience are also required.

Zhejiang Novus Pharmaceuticals Co. Ltd. is required to address all deficiencies and resubmit the application as a complete response within one year to initiate a new review cycle. The FDA offers the option of a meeting to discuss the necessary steps for approval.