Drug News

Stay up-to-date on the latest drug news. Learn about new drug approvals, labeling changes, expanded indications, recalls, and approvals of generic formulations. These drug news updates are compiled from the latest information from Facts & Comparisons® and the U.S. Food and Drug Administration.

(Updated February 7, 2018)

The FDA has approved the following expanded indications:
  • Avycaz (ceftazidime/avibactam) intravenous injection to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in patients 18 years and older. Avycaz is also approved in combination with metronidazole to treat complicated intra-abdominal infections in patients 18 years and older, and to treat complicated urinary tract infections including pyelonephritis in patients 18 years and older.
  • Feraheme (ferumoxytol) intravenous injection for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have chronic kidney disease (CKD). Feraheme was previously approved for the treatment of IDA only in adult patients with CKD.
  • Zomacton (somatropin) subcutaneous injection to include the replacement of endogenous growth hormone (GH) in adults with GH deficiency. Zomacton is also indicated for the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous GH.
 
The FDA has approved the following Boxed Warning:
  • Ocaliva (obeticholic acid) oral tablets regarding the risk of hepatic decompensation and failure in incorrectly dosed primary biliary cholangitis patients with Child-Pugh class B or C or decompensated cirrhosis. 
 

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