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FDA approved ivacaftor (Kalydeco, Vertex Pharmaceuticals) for the treatment of a rare form of cystic fibrosis in patients aged 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator gene.

Indian drug giant Ranbaxy has accepted a consent decree filed by the U.S. Department of Justice on behalf of FDA. The decree, which must still be accepted by the U.S. District Court for the District of Maryland, requires Ranbaxy to fix long-standing manufacturing problems at plants in India as well as a plant in the United States.

Aspirin prophylaxis in people without prior cardiovascular disease does not appear to reduce cardiovascular death or cancer mortality, however it was associated with reductions in nonfatal myocardial infarction, according to the results of a meta-analysis published online January 9 in the Archives of Internal Medicine.

FDA approved ingenol mebutate (Picato, LEO Pharma) gel (0.015%, 0.05%) for the topical treatment of actinic keratosis (AK). It is the first topical AK therapy that can be used for as few as 2 or 3 consecutive days.

Approximately 1 in 100 patients undergoing total or partial knee replacement surgery and 1 in 200 patients undergoing total or partial hip replacement surgery will experience a venous thromboembolism event, including deep vein thrombosis and pulmonary embolism, before being discharged from the hospital, according to a study reported January 18 in the Journal of the American Medical Association.

FDA is requiring that manufacturers of tumor necrosis factor blockers perform enhanced safety surveillance in children, teenagers, and young adults, the agency said on November 3 in an ongoing safety review of this class of biologic products.