Formulary staff
FDA drug approvals: January 2014
FDA approvals, complete response, fast-track designations, priority review, first-time generic approval
FDA approves Kcentra for warfarin reversal in emergency surgery patients
FDA expanded the indication for Prothrombin Complex Concentrate [Human] (Kcentra, CSL Behring) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients needing an urgent surgery or other invasive procedure.
Amneal launches delayed-release proton pump inhibitor for GERD
Amneal Pharmaceuticals will start shipping its branded Esomeprazole Strontium 49.3 mg delayed-release capsules on December 18 to three major U.S. wholesalers. Its capsules contain the same active ingredient, esomeprazole, in a different salt form as found in Nexium (esomeprazole magnesium).
FDA proposed rule requires antibacterial soap manufacturers to prove safety, effectiveness
Manufacturers of antibacterial hand soap and body wash will be required to show that their products are more effective than plain soap and water in preventing illness and the spread of infection, under a FDA-proposed rule.
Diabetes: A risk factor for liver cancer across ethnic groups
Diabetes was associated with an increased risk for developing hepatocellular carcinoma, a type of liver cancer, and this association was highest for Latinos, followed by Hawaiians, African-Americans, and Japanese-Americans, according to results presented here at the Sixth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, held Dec. 6-9, in Atlanta.
Anti-diabetic drugs can lower cancer risk by 32%
A specific type of diabetes drug can decrease the risk of cancer in female patients with type 2 diabetes up to 32%, according to a study published in Diabetes, Obesity and Metabolism. People with type 2 diabetes have a higher rate of cancer development and recurrence compared to the general population.
Treat critically ill kids with flu fast with NAIs
Rapidly treating children who are critically ill with influenza with neuraminidase inhibitors saves lives, according to a new study, but physicians are frequently not using the drugs.
FDA study helps provide understanding of rising rates of whooping cough, response to vaccination
A new study is helping to provide a better understanding of vaccines for whooping cough, the common name for the disease pertussis. Based on an animal model, the study conducted by FDA and published November 25, 2013, in The Proceedings of the National Academy of Sciences, shows that acellular pertussis vaccines licensed by FDA are effective in preventing the disease among those vaccinated, but suggests that they may not prevent infection from the bacteria that causes whooping cough in those vaccinated or its spread to other people, including those who may not be vaccinated.
Sodium levels in “fizzy” medications may increase cardiovascular risks
Taking effervescent, dispersible, and soluble medications that contain sodium long term increase the risk of cardiovascular events, including heart attacks and strokes, according to a study published in the British Medical Journal.
FDA approves Xiaflex for Peyronie’s disease
FDA approved a new use for collagenase clostridium histolyticum (Xiaflex, Auxilium Pharmaceuticals) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.

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