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FDA News Briefs for Monday, February 5, 2018

February 5, 2018

These Food and Drug Administration (FDA) developments came in late last week:


Boxed Warning Added to Ocaliva Label

The FDA announced last Thursday that Ocaliva (obeticholic acid; Intercept Pharmaceuticals) has been incorrectly dosed daily instead of weekly in patients, increasing the risk of serious liver injury. As a result, the agency will be adding a new boxed warning to the Ocaliva label to ensure correct dosing. More Information.  


FDA Expands Indications for Avycaz

Avycaz (ceftazidime and avibactam; Allergan Plc) is now approved by the FDA to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults caused by the following susceptible gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenza. The FDA first approved Avycaz in 2015. Avycaz is administered by intravenous infusion. More Information.


FDA Updates Public on Efforts to Address IV Saline Shortages

The FDA Commissioner issued a statement on February 1, 2018, to update the public on ongoing agency efforts to mitigate the impact of intravenous saline shortages during this flu season. IV saline bag shortages are a long standing problem across the United States. More Information.