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And other news from the US Food and Drug Administration
November 2015, Vol 3, No 11 - Inside Drug Update

New Drugs/Devices

The following are recent approvals announced by the US Food and Drug Administration (FDA):

  • Aristada (aripiprazole lauroxil) extended-release injection was approved to treat adults with schizophrenia; the most common side effect reported during clinical trials was akathisia.
  • Strensiq (asfotase alfa) is the first FDA-approved treatment for perinatal, infantile, and juvenile-onset hypophosphatasia; common side effects associated with this drug include injection site reactions, hypersensitivity reactions, lipodystrophy at the injection site, and ectopic calcifications of the eyes and kidneys.
  • Veltassa (patiromer for oral suspension), a powdered medication that patients need to mix with water, was approved for the treatment of patients with hyperkalemia; the most common side effects of this medication include constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort, and flatulence.
  • Coagadex (Coagulation Factor X, Human) was approved for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in patients aged ≥12 years with hereditary Factor X (10) deficiency.
  • Praxbind (idarucizumab) was approved for patients taking the anticoagulant Pradaxa (dabigatran), who, during emergencies, require reversal of Pradaxa’s blood-thinning effects; patients should resume their anticoagulant therapy as soon as it is medically appropriate.
  • Imlygic (talimogene laherparep­vec) is the first FDA-approved oncolytic virus therapy for the treatment of patients with melanoma lesions in the skin and lymph nodes; fatigue, chills, fever, nausea, flulike symptoms, and pain at the injection site were the drug’s most commonly reported side effects.
  • Yondelis (trabectedin) was approved for the treatment of patients with specific soft tissue sarcomas that are unresectable or metastatic.
  • Onivyde (irinotecan liposome injection) was approved in combination with fluorouracil and leucovorin to treat patients with metastatic pancreatic cancer who have previously been treated with gemcitabine-based chemotherapy.
  • Opdivo (nivolumab) was approved to treat patients with metastatic non–small-cell lung cancer whose disease progressed during or after platinum-based chemotherapy.

Announcement

  • According to an announcement, the FDA recently filed complaints initiating the first-ever No-Tobacco-Sale Order (NTSO) actions for a group of retailers who have repeatedly violated certain restrictions on the sale and distribution of tobacco products, including sales to minors. Under the law, the FDA may pursue an NTSO against retailers that have a total of ≥5 repeated violations of those restrictions during compliance inspections within 36 months.



  1. US Food and Drug Administration. Press announcements. www.fda.gov/NewsEvents/News room/PressAnnouncements. Updated November 3, 2015. Accessed November 3, 2015.
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