• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
 
Generic Name:  copanlisib
Date Designated:  04/16/2021
Orphan Designation:  Treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Bayer HealthCare Pharmaceuticals Inc.
100 Bayer Blvd
P.O.Box 915
Whippany, New Jersey 07981-0915
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
-
-