Janssen Pharmaceuticals received a green light from the FDA for anticoagulant Xarelto (rivaroxaban tablets). The approval is for use once daily in preventing deep vein thrombosis after knee or hip replacement surgery. Janssen holds US marketing rights to the blood thinner, and Bayer HealthCare's sales force will support Janssen efforts by detailing Xarelto in certain hospital accounts.
Some statements used by Novartis in a recorded phone script and professional slides touting its Menveo meningitis vaccine were “false and misleading,” the FDA said in an untitled letter to the company posted last Friday. The promotional materials falsely suggest that Menveo is approved for use consistent with an influential federal vaccine panel's recommendations. Regulators requested that Novartis immediately cease dissemination of the materials. A Novartis spokesperson told Reuters its vaccine unit has already done so.