Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Rivaroxaban (Centre Daily Times)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for rivaroxaban, an investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery.

Ikaria(R) Receives FDA Orphan Drug Designation For Inhaled Carbon Monoxide For Delayed Graft Function In Solid Organ ... (Medical News Today)
Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inhaled carbon monoxide for use in the reduction of the incidence and severity of delayed graft function (DGF) in patients undergoing solid organ transplantation. Ralf Rosskamp, M.D.

Osteotech's Plexur M(TM) Biocomposite Receives FDA Clearance In Spine (Medical News Today)
Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic solutions for regenerative healing, announced that the United States Food and Drug Administration ("FDA") has cleared its 510(k) submission for Plexur M(TM) Biocomposite for use in spinal applications.