New Complete Response Letter for Janssen, Bayer’s Xarelto

July 17, 2013
Janssen said June 28 it received another complete response letter (CRL) for an sNDA regarding its anticoagulant Xarelto, although this time it’s for a separate indication. In May, the J&J subsidiary and its partner Bayer received a second CRL from the FDA, after an initial letter back in September, for a different sNDA associated with the drug.
Washington Drug Letter