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 April 16, 2019)

The FDA has approved the following drug:
  • Asceniv (immune globulin intravenous, human – slra) liquid for intravenous injection to treat primary humoral immunodeficiency in adults and adolescents (12 to 17 years of age). Labeling includes a Boxed Warning for the risk of thrombosis, renal dysfunction, and acute renal failure.
  • Ambrisentan oral tablets, the generic version of Letairis, to treat pulmonary arterial hypertension, (WHO Group 1) to increase exercise capacity and delay worsening of the condition. Labeling includes a Boxed Warning for the risk of embryo-fetal toxicity.
  • Avaclyr (acyclovir ophthalmic ointment) to treat acute herpetic keratitis in patients with herpes simplex (HSV-1 and HSV-2) virus.
  • Balversa (erdafitinib) oral tablets to treat adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations and has progressed during or following at least 1 line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
  • Dovato (dolutegravir/lamivudine) oral tablets to treat HIV-1 infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato. This is the first FDA-approved 2-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV. 
  • Evenity (romosozumab-aqqg) subcutaneous injection to treat osteoporosis in postmenopausal women at high risk for fracture (history of osteoporotic fracture, or multiple risk factors for fracture); or patients who have failed or cannot take other available osteoporosis medications. Labeling includes a Boxed Warning for the potential risk of myocardial infarction, stroke, and cardiovascular death.
  • Jatenzo (testosterone undecanoate) oral capsules as testosterone replacement therapy in adult males for conditions related to a deficiency or absence of endogenous testosterone. Labeling includes a Boxed Warning for the risk of hypertension.
  • Mayzent (siponimod) oral tablets to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 
  • Zelnorm (tegaserod) oral tablets for irritable bowel syndrome with constipation (IBS-C) in adult women younger than 65 years. Zelnorm was originally approved by the FDA in 2002 to treat IBS-C in women, but it was voluntarily withdrawn from the US market in 2007 due to potential safety reasons. 
The FDA has approved the following new indications:
  • Cimzia (certolizumab pegol) subcutaneous injection to include treatment of adults with active non-radiographic axial spondyloarthritis with signs of inflammation. Cimzia is also approved for Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Labeling includes a Boxed Warning regarding the risks of serious infections and malignancy.
The FDA has approved the following expanded indication:
  • Ibrance (palbociclib) oral capsules in combination with specific endocrine therapies for HR-positive, HER2-negative advanced or metastatic breast cancer to include male patients. Breast cancer is rare in males.
  • Keytruda (pembrolizumab) intravenous injection to include use as a single agent for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC), who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (tumor proportion score ≥1%), with no EGFR or ALK genomic tumor aberrations. 
 The FDA has approved the following Boxed Warning revision:
  • Addyi (flibanserin) oral tablets to include a warning against the use of Addyi and alcohol together, within 2 hours, due to an increase in the risk of severe hypotension and syncope; therefore, taking Addyi sooner than 2 hours after alcohol consumption is contraindicated. Previously, the Boxed Warning stated Addyi was contraindicated with alcohol. Addyi is indicated to treat premenopausal women with acquired, generalized hypoactive sexual desire disorder.

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