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.

DRUG NEWS
(Updated September 29, 2020)

The FDA has approved the following drugs:
  • Fetroja (cefiderocol) intravenous injection in adults to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by certain susceptible Gram-negative microorganisms, including Acinetobacter baumannii complex and Pseudomonas aeruginosa. Fetroja is also approved for complicated urinary tract infections, including pyelonephritis.
  • Nucala (mepolizumab) subcutaneous injection to treat adult and pediatric patients 12 years and older with hypereosinophilic syndrome for at least 6 months without an identifiable non-hematologic secondary cause. Nucala is also approved for maintenance treatment of severe asthma and for eosinophilic granulomatosis with polyangiitis.
The FDA has approved the following new indications:
  • Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) oral inhalation powder to treat asthma in patients 18 years and older. Trelegy Ellipta is also approved for the maintenance treatment of chronic obstructive pulmonary disease.
The FDA has approved the following expanded indications:
  • Eraxis (anidulafungin) intravenous injection to treat candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in pediatric patients 1 month and older. Eraxis was already approved in adults for this indication, and to treat esophageal candidiasis.
  • Haegarda (C1 esterase inhibitor [human]) solution for subcutaneous injection (after reconstitution) for routine prophylaxis against hereditary angioedema attacks in patients 6 years and older. Haegarda was previously approved in patients 13 years and older.
  • Kalydeco (ivacaftor) oral tablets and granules to treat cystic fibrosis (CF) in patients 4 months and older who have 1 mutation in the CF transmembrane conductance regulator gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data. Kalydeco was previously approved for patients 6 months and older.
 
 

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