Determination That PREZISTA (Darunavir) Tablets, 400 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

الملخص

The Food and Drug Administration (FDA or the Agency) has determined that PREZISTA (darunavir) tablets, 400 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for darunavir tablets, 400 mg, if all other legal and regulatory requirements are met.