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Dear Ms. Gonzalez:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #2257. Based on our evaluation, it appears that you have included a marketing end date of May 23, 2022, indicating that the product will no longer be available in U.S. commercial distribution, but you have not taken corrective measures to address the listing deficiencies. Although the Warning Letter #2257 is closed since the drug listing is discontinued, a compliance case against the data will remain open to prevent relisting since the corrective measures were not taken in this revision to address the listing deficiencies. Future FDA regulatory activities will further assess the adequacy and sustainability of these actions. 

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority requirements. The Agency expects you and your firm to continue to monitor your state of compliance and maintain compliance. This letter will not preclude any future regulatory action should violations be observed during additional data review projects, future inspections, or through other means. 

Sincerely,
/S/
Carolyn E. Becker, J.D. 
Director, Office of Unapproved Drugs & Labeling Compliance
Office of Compliance 
Center for Drug Evaluation and Research 
U.S. Food and Drug Administration