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 May 10, 2021)

The FDA has approved the following drugs:
  • A higher dose of naloxone nasal spray to treat opioid overdose. The newly approved product delivers naloxone 8 mg into the nasal cavity. Previously approved doses of naloxone were 2 mg and 4 mg nasal spray.
  • Zynlonta (loncastuximab tesirine-lpyl) intravenous injection to treat adult patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.
The FDA has approved the following new indications:
  • Farxiga (dapagliflozin) oral tablets to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. Farxiga is also approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors; and to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II to IV) with reduced ejection fraction.
  • Ferriprox (deferiprone) oral tablets now approved to treat iron overload following transfusion in adult and pediatric patients 8 years and older with thalassemia syndromes; previously approved for this indication in adults only. Ferriprox is also now approved to treat transfusion-related iron overload in adult and pediatric patients 8 years and older with sickle cell disease or other anemias. Major risks include agranulocytosis and neutropenia.
  • Natroba (spinosad) topical suspension to treat scabies infestations in adult and pediatric patients 4 years and older. Natroba is also indicated to topically treat head lice infestations in adult and pediatric patients 6 months and older.
The FDA has approved the following expanded indications:
  • Diovan (valsartan) oral tablets to include patients 1 year and older to treat hypertension (previously approved in patients 6 years and older). Labeling includes a Boxed Warning regarding the risk of fetal toxicity.
  • Keytruda (pembrolizumab) intravenous injection to include first-line treatment (in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy) of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. 
  

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