InvestorsHub Logo

DewDiligence

05/21/12 1:10 PM

#142310 RE: DewDiligence #137995

FDA briefing docs for Xarelto in ACS:

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm304754.htm

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm285415.htm

The panel meeting is 5/23/12; the PDUFA date is in late June. Note that JNJ has submitted a separate Xarelto NDA for the (partially overlapping) indication of PCI secondary to ACS (#msg-75391993).