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 July 21, 2017)

The FDA has approved the following drugs:‚Äč
  • Tremfya (guselkumab) subcutaneous injection for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 
  • Nerlynx (neratinib) oral tablets for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. Nerlynx is the first extended adjuvant therapy for this type of cancer.
  • Prasugrel hydrochloride oral tablets, the generic version of Effient, which is indicated to reduce thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are managed with percutaneous coronary intervention (PCI) as follows: patients with unstable angina or non-ST–elevation myocardial infarction; patients with ST-elevation myocardial infarction when managed with either primary or delayed PCI. Labeling includes a Boxed Warning regarding bleeding risk.
  • Zypitamag (pitavastatin magnesium) oral tablets for the treatment of patients with primary hyperlipidemia or mixed dyslipidemia in conjunction with diet, to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, and triglycerides; and to increase high-density lipoprotein cholesterol.
  • Vosevi (sofosbuvir/velpatasvir/voxilaprevir) oral tablets for the treatment of adults with chronic hepatitis C virus (HCV) without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have:
    • genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor,
    • genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.
    • Prescribing information includes a Boxed Warning regarding the risk of hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV.


 
 

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