Novavax, Inc. reported that the Food and Drug Administration (FDA) has completed its review of the Estrasorb New Drug Application (NDA). During the review process, no issues regarding the efficacy or safety of Estrasorb have been communicated by the review division.
The agency has requested additional information with respect to the Chemistry Manufacturing and Controls (CMC) section of the filing.
Based upon ongoing discussions with the FDA, Novavax believes the most advantageous approach to resolving the outstanding CMC questions is to voluntarily withdraw the NDA and resubmit once all the responses to the CMC questions have been prepared. Novavax continues to work together with the FDA in order to submit the additional information in a timely fashion.
Novavax is committed to ensuring quality and compliance with current Good Manufacturing Practices. Novavax believes the CMC questions can be satisfactorily addressed and will ultimately lead to a favorable review by the FDA.