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 October 12, 2018)

The FDA has approved the following drugs:
  • Revcovi (elapegademase-lvlr) intramuscular injection to treat adenosine deaminase severe combined immune deficiency in pediatric and adult patients.
  • Tegsedi (inotersen) subcutaneous injection to treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Tegsedi was approved with a Risk Evaluation and Mitigation Strategy (REMS). Labeling includes a Boxed Warning regarding the risk of thrombocytopenia and glomerulonephritis.
The FDA has approved the following expanded indications:
  • Coagadex (Coagulation Factor X [Human]) lyophilized powder for intravenous injection to reduce bleeding episodes, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in children younger than 12 years with hereditary factor X deficiency. Coagadex was previously approved only in children older than 12 years and adults.
  • Gardasil 9 (human papillomavirus [HPV] 9-valent vaccine, recombinant) suspension for intramuscular injection to prevent certain cancers and diseases caused by the 9 HPV types covered by the vaccine to include women and men 27 through 45 years old. The vaccine was previously approved only for use in males and females 9 through 26 years of age.
The FDA has approved the following new indication:
  • Xarelto (rivaroxaban) oral tablets, in combination with aspirin, to decrease the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in patients with chronic coronary artery disease or peripheral artery disease. Xarelto is also indicated to decrease the risk of stroke and systemic embolism in nonvalvular atrial fibrillation, to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), to reduce the risk of DVT recurrence and/or PE, and prophylaxis of DVT following hip or knee replacement surgery. Labeling includes a Boxed Warning regarding the risk of thrombotic events, and spinal/epidural hematoma following premature discontinuation of the drug. 
 

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