Secura Bio, Inc.; Withdrawal of Approval of Relapsed or Refractory Follicular Lymphoma Indication for COPIKTRA

摘要

The Food and Drug Administration (FDA) is announcing that it is withdrawing approval of the relapsed or refractory follicular lymphoma indication for COPIKTRA (duvelisib) Capsules, approved under new drug application 211155, held by Secura Bio, Inc., 1995 Village Center Circle, Suite 128, Las Vegas, NV 89134. Secura Bio, Inc. voluntarily requested that the Agency withdraw approval of this indication and has waived its opportunity for a hearing.