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 April 22, 2021)

The FDA has approved the following drugs:
  • Barhemsys (amisulpride) intravenous injection in adults to prevent postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class; and to treat PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.
  • Jemperli (dostarlimab-gxly) intravenous injection to treat adults with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen. 
  • Nextstellis (drospirenone/estetrol) oral tablets to prevent pregnancy in females of reproductive potential. Nextstellis labeling includes a Boxed Warning regarding the risks of cigarette smoking and serious cardiovascular events.
The FDA has approved the following new indications:
  • Opdivo (nivolumab) intravenous injection, in combination with fluoropyrimidine- and platinum-containing chemotherapy, to treat patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Opdivo is also approved to treat several other forms of cancer (see prescribing information). 
  • Trodelvy (sacituzumab govitecan-hziy) intravenous injection to treat adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 or programmed death-ligand 1 inhibitor. Trodelvy is also approved to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received 2 or more prior systemic therapies, at least 1 of them for metastatic disease. Trodelvy labeling includes a Boxed Warning regarding the risks of neutropenia and diarrhea. 
The FDA has approved the following expanded indications:
  • Evekeo ODT (amphetamine sulfate) orally disintegrating tablets to include patients 3 to 17 years of age to treat attention deficit hyperactivity disorder. Evekeo ODT was previously approved in patients 6 to 17 years of age. Evekeo ODT is dispensed with a Medication Guide, and its labeling includes a Boxed Warning regarding the risks of abuse and dependence.
  • Ragwitek (short ragweed pollen allergen extract) sublingual tablets to include children and adolescents 5 through 17 years of age for the treatment of short ragweed pollen–induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Ragwitek was previously approved for use in adults 18 through 65 years of age. Labeling includes a Boxed Warning regarding the risk of severe allergic reactions.
  

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