Determination That DUEXIS (Ibuprofen and Famotidine) Tablet, 800 Milligrams and 26.6 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

The Food and Drug Administration (FDA or Agency) has determined that DUEXIS (ibuprofen and famotidine) tablet, 800 milligrams (mg) ibuprofen and 26.6 mg famotidine, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.