The U.S. Department of Justice announced that McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, pleaded guilty to selling children's versions of over-the-counter medications such as Tylenol and Motrin that contained contaminants including nickel and chromium particles. The company also agreed to pay $25 million to settle the case and improve safety measures before reopening its manufacturing facility in Fort Washington, Pa.
Bayer and Johnson & Johnson are initiating two late-stage trials of the anticoagulant rivaroxaban after failing to get expanded FDA approval for the prevention of cardiovascular events in patients with acute coronary syndrome. One trial will involve individuals with chronic heart failure and significant coronary artery disease. The other will include patients with nonvalvular atrial fibrillation.
Johnson & Johnson applied for FDA approval of anti-clotting drug Xarelto (rivaroxaban) as a treatment for acute coronary syndrome.
Xarelto, co-developed by Bayer HealthCare, is already approved for patients with atrial fibrillation and
those undergoing knee- or hip-replacement surgery.
Johnson & Johnson and Bayer plan to apply by year-end for U.S. and EU authorization to promote Xarelto, or rivaroxaban, as treatment for acute coronary syndrome. The filings will include Phase III trial data showing that Xarelto combined with standard anti-clotting therapy reduces the incidence of stroke, heart attack and cardiovascular death. Xarelto was approved for certain patients undergoing surgery and recommended for preventing stroke related to atrial fibrillation.
Johnson & Johnson is turning its McNeil Consumer Healthcare unit into a separate organization to focus on improving "quality and compliance, and the critical task of restoring" over-the-counter brands affected by a string of recalls. The remaining divisions of J&J's consumer group will be reorganized into four regions, including North America and Asia-Pacific. The changes will take effect Monday.