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 November 17, 2017)

The FDA has approved the following drugs:‚Äč
 
  • Abilify MyCite (aripiprazole) oral tablets with sensor, a new Abilify product with an embedded sensor that records the ingestion of the medication. Abilify MyCite, like Abilify, is approved to treat adults with schizophrenia, adults with bipolar I disorder, and for adjunctive treatment of adults with major depressive disorder. Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or may not occur. Labeling includes a Boxed Warning regarding the risk of increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors.
  • Fasenra (benralizumab) subcutaneous injection indicated for the add-on maintenance treatment of patients with severe asthma 12 years and older, and with an eosinophilic phenotype. Fasenra is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
  • Hemlibra (emicizumab-kxwh) once-weekly subcutaneous injection for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors. Labeling includes a Boxed Warning regarding the risk for thrombotic microangiopathy and thromboembolism.
  • Mepsevii (vestronidase alfa-vjbk) intravenous injection to treat pediatric and adult patients with mucopolysaccharidosis VII, also known as Sly syndrome. The manufacturer is required by the FDA to conduct a postmarketing study to evaluate the long-term safety of the product. Labeling includes a Boxed Warning regarding the risk of anaphylaxis
 
The FDA has approved the following expanded indication:
 
  • Tekturna (aliskiren) oral pellets for the treatment of hypertension in adults and pediatric patients 6 years and older. Tekturna oral pellets are provided in a capsule that should be opened and the contents ingested per labeling instructions. Tekturna oral tablets were previously approved only for adults. Labeling includes a Boxed Warning regarding the risk of fetal toxicity. Tekturna oral pellets should be available in 2018.
 

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