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 10, 2019)

The FDA has approved the following drugs:
  • Aklief (trifarotene) topical cream to treat acne vulgaris in patients 9 years and older.
  • Beovu (brolucizumab-dbll) intravitreal injection to treat neovascular (wet) age-related macular degeneration.
  • Scenesse (afamelanotide) implant to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria.
The FDA has approved the following new indications:
  • Descovy (emtricitabine/tenofovir alafenamide) oral tablets for at-risk adults and adolescents weighing at least 35 kg for HIV-1 pre-exposure prophylaxis to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex (not studied in this population). Descovy is also indicated to treat HIV-1 infection in combination with other antiretroviral agents in adults and pediatric patients. One major risk includes HIV-1 and hepatitis B coinfection.
  • Entresto (sacubitril/valsartan) oral tablets to treat symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients 1 year and older. Entresto is also indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure (NYHA class II to IV) and reduced ejection fraction. One major risk is fetal toxicity.
The FDA has approved the following expanded indications:
  • Tybost (cobicistat) oral tablets to increase systemic exposure of darunavir (once-daily dosing regimen) in combination with other antiretroviral agents to treat HIV-1 infection in pediatric patients weighing at least 40 kg. Tybost is also indicated to treat HIV-1 infection in adults to increase systemic exposure of atazanavir or darunavir (once-daily dosing regimen) in combination with other antiretroviral agents; and to treat HIV-1 infection in pediatric patients weighing at least 35 kg to increase systemic exposure of atazanavir in combination with other antiretroviral agents.

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