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 December 14, 2018)

The FDA has approved the following drugs:
  • Firdapse (amifampridine) oral tablets to treat Lambert-Eaton myasthenic syndrome (LEMS) in adults.
  • Truxima (rituximab-abbs) intravenous injection, a biosimilar to Rituxan (rituximab) to treat adult patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent; previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy. Labeling includes a Medication Guide and a Boxed Warning regarding the risk of fatal infusion reactions, severe mucocutaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy. 
  • Xospata (gilteritinib) oral tablets to treat adult patients who have relapsed or refractory acute myeloid leukemia with an FLT3 mutation (detected by an FDA-approved test).
The FDA has approved the following expanded indications:
  • Astagraf XL (tacrolimus extended-release) oral capsules to include pediatric patients (previously approved for adults only) as prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants. Astagraf XL labeling includes a Medication Guide and a Boxed Warning regarding the risk of malignancies and serious infections in transplant patients and increased mortality in female liver transplant patients.
  • Viread (tenofovir disoproxil fumarate) oral tablets and oral powder to include the treatment of chronic hepatitis B virus in adults and pediatric patients 2 years and older weighing at least 10 kg. This indication was previously approved for patients 12 years and older. Viread is also indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years and older weighing at least 10 kg. Labeling includes a Boxed Warning regarding the risk of posttreatment acute exacerbation of hepatitis B.

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