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 January 11, 2017)

The FDA has approved the following indications:
  • Arymo ER (morphine sulfate) extended-release oral tablets to manage severe pain requiring daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Labeling includes a Boxed Warning regarding addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other CNS depressants. Although Arymo ER is formulated to make abuse by injection difficult, abuse by intravenous, intranasal, and oral routes is still possible.
The FDA has approved the following expanded indications:
  • Glyxambi (empagliflozin/linagliptin) oral tablets to include reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. Glyxambi is also approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.
  • Lucentis (ranibizumab) Intravitreal injection to include the treatment of patients with myopic choroidal neovascularization. Lucentis is also approved for the treatment of patients with neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy in patients with DME.
The FDA has approved the following Boxed Warnings:
  • Demerol (meperidine hydrochloride) tablets regarding addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; cytochrome P450 3A4 interaction; risks from concomitant use with benzodiazepines or other CNS depressants; and monoamine oxidase inhibitors interactions. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
  • Librium (chlordiazepoxide hydrochloride) capsules regarding risks from concomitant use with opioids. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
  • Sufentanil citrate (Sufenta) injection regarding addiction, abuse, and misuse, which can lead to overdose and death.
  • Percodan (oxycodone/aspirin) oral tablets regarding addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; cytochrome P450 3A4 interaction; and risks from concomitant use with benzodiazepines or other CNS depressants. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. 
 

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