Bausch Health Ireland Limited – FDA CRL

The FDA issued a Complete Response Letter (CRL) to Bausch Health Ireland Limited for its New Drug Application (NDA 211039) for fluorescein sodium and benoxinate hydrochloride ophthalmic solution. The agency found the application unacceptable due to significant manufacturing deficiencies identified during a recent inspection of a manufacturing facility. Investigators observed objectionable conditions, indicating non-compliance with current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211) concerning the methods, facilities, and controls for the drug substance. Additionally, Bausch Health failed to provide requested data for two process deficiencies, needs to establish a control strategy for a manufacturing step, and provided incomplete responses to a May 2019 information request, suggesting an alternative of providing a Drug Master File Letter of Authorization. To gain approval, Bausch Health must satisfactorily resolve all observed objectionable conditions, ensure all manufacturing facilities meet CGMP standards, provide the missing process data, complete information requests, and include a comprehensive safety update upon resubmission. The company has one year to resubmit the application, addressing all deficiencies, under the framework of 21 CFR 314.110.