Supplemental New Drug Application for IMBRUVICA™ (ibrutinib) submitted to the U.S. FDA
9 April 2014 | By Johnson & Johnson
Janssen Research & Development, LLC (“Janssen”) today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. This regulatory submission is based on data from the Phase 3 RESONATE™ study in relapsed or…