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 November 20, 2020)

The FDA has approved the following drugs:
  • Veklury (remdesivir) intravenous injection for adults and pediatric patients 12 years and older and weighing at least 40 kg to treat coronavirus disease 2019 (COVID-19) requiring hospitalization. Veklury should only be administered in a hospital or in a health care setting capable of providing acute care comparable with inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.
  • Sklice (ivermectin) topical lotion for nonprescription use to treat head lice in patients 6 months and older. Sklice was initially approved as a prescription drug in February 2012.
  • Sutab (sodium sulfate/magnesium sulfate/potassium chloride) oral tablets for cleansing of the colon in preparation for colonoscopy in adults. Sutab will be available by prescription on January 1, 2021.
The FDA has approved the following new indications:
  • Brilinta (ticagrelor) oral tablets to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score of 5 or less) or high-risk transient ischemic attack. Brilinta is also approved to reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome or a history of MI and to reduce the risk of first MI or stroke in patients with coronary artery disease at high risk for such events. One major risk is bleeding. An aspirin dose above 100 mg reduces the effectiveness of Brillinta and Brillinta is contraindicated in patients with hypersensitivity to ticagrelor.
  • Keytruda (pembrolizumab) intravenous injection may now be used, in combination with chemotherapy, to treat patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 (combined positive score ≥10) as determined by an FDA-approved test. Keytruda is also approved to treat several other forms of cancer (see prescribing information). 
  • Vimpat (lacosamide) oral solution, oral tablets, and intravenous injection are now approved for adjunctive therapy to treat primary generalized tonic-clonic seizures in patients 4 years and older. The FDA has also approved an expanded indication for Vimpat intravenous injection to include the treatment of partial-onset seizures in adult and pediatric patients 4 years and older; the injection was previously approved for this indication in adults only. 
The FDA has approved the following expanded indications:
  • Selzentry (maraviroc) oral tablets and oral solution, in combination with other antiretroviral agents, to treat only CCR5-tropic HIV-1 infection in adults and pediatric patients weighing at least 2 kg. Selzentry was previously approved for this indication in patients 2 years and older and weighing at least 10 kg. A major risk is hepatotoxicity.
 

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