On December 22, 2014 Pharmacyclics reported that the U.S Food and Drug Administration (FDA) has provided a Prescription Drug User Fee Act (PDUFA) target date of April 17, 2015 by which time the FDA is planning to finalize its review of a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) as a treatment for patients with Waldenstrom’s macroglobulinemia (WM) (Press release Pharmacyclics, DEC 22, 2014, View Source [SID:1234501234]). IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

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