Ortho-McNeil announced that the US Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for rivaroxaban, an oral, once-daily anticoagulant. The NDA, filed in July 2008 by Johnson & Johnson Pharmaceutical Research and Development, LLC (J&JPRD) on behalf of Ortho-McNeil, seeks approval to market rivaroxaban for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery.

Ortho-McNeil is currently evaluating the FDA's complete response letter, and will respond to the agency's questions as quickly as possible. The FDA has not requested that any new clinical or non-clinical studies be conducted evaluating the efficacy or safety of rivaroxaban for this indication as a prerequisite for approval.

"We are confident in the positive benefit-risk profile of rivaroxaban and will promptly address the questions set forth by the FDA," said Peter DiBattiste, vice president, Johnson & Johnson Pharmaceutical Research and Development.

On March 19, 2009, the FDA's Cardiovascular and Renal Drugs Advisory Committee agreed by a 15-2 vote that the available clinical data for rivaroxaban demonstrated a favourable benefit-risk profile.

The extensive programme of clinical trials supporting possible approval of rivaroxaban by health care regulatory authorities will make rivaroxaban the most studied oral, direct Factor Xa inhibitor in the world today.

Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharma (OMJPI), a Johnson & Johnson company, is committed to providing innovative, high-quality prescription medicines and resources for healthcare providers and their patients in hospitals and other care facilities.