FDA CRL - Bayer HealthCare LLC

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Bayer HealthCare LLC for their New Drug Application (NDA 218506) concerning a Naproxen sodium capsule. The FDA determined the application cannot be approved in its current form due to several significant issues.

Key deficiencies include inadequate nonclinical data to support the application. Additionally, a pre-approval inspection of a manufacturing facility identified significant issues documented in an FDA Form 483, which adversely impact the facility's ability to perform its designated functions and affect product quality. The proposed proprietary name was conditionally acceptable but requires resubmission after all deficiencies are resolved, and comments on labeling are reserved pending resolution of other issues.

Under the FDA's regulatory framework for NDA review, Bayer HealthCare LLC must take several actions. They are required to provide adequate nonclinical data and ensure the inspected facility submits satisfactory responses to its Form 483 deficiencies, including these response dates in their resubmission. A comprehensive safety update, as per 21 CFR 314.50(d)(5)(vi)(b), is also mandated, encompassing all nonclinical and clinical study safety information, adverse event re-tabulations, and worldwide safety experience. Bayer must resubmit the complete application within one year, fully addressing all identified deficiencies, as the product cannot be legally marketed until formal approval. A meeting with the FDA can be requested to discuss these requirements.