Determination That DOVONEX (Calcipotriene) Ointment, 0.005%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

The Food and Drug Administration (FDA) is announcing its determination that DOVONEX (calcipotriene) Ointment, 0.005%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for calcipotriene Ointment, 0.005%, if all other legal and regulatory requirements are met.