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 August 13, 2018)

The FDA has approved the following drugs:
  • Annovera (segesterone acetate/ethinyl estradiol) vaginal ring for women of reproductive age to prevent pregnancy. It is the first vaginal ring contraceptive that can be used for an entire year.
  • Arakoda (tafenoquine) oral tablets as prophylaxis of malaria in patients 18 years and older. 
  • Mulpleta (lusutrombopag) oral tablets to treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
  • Omegaven (fish oil triglycerides) intravenous injectable emulsion as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis.
  • Onpattro (patisiran) lipid complex intravenous injection to treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients.
  • Panzyga (immune globulin intravenous, human – ifas) 10% liquid preparation to treat primary humoral immunodeficiency in patients 2 years and older, including, but not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies; and to treat adult patients with chronic immune thrombocytopenia to raise platelet counts to control or prevent bleeding. Labeling includes a Boxed Warning regarding the risks of thrombosis, renal dysfunction, and acute renal failure.
  • Poteligeo (mogamulizumab-kpkc) intravenous injection to treat adult patients with relapsed or refractory mycosis fungoides or S├ęzary syndrome after at least 1 prior systemic therapy.
The FDA has approved the following expanded indications:
  • Granix (tbo-filgrastim) subcutaneous injection to include treatment of pediatric patients 1 month and older. Granix is used to reduce the length of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Granix was previously approved for adults only.
  • Nuvessa (metronidazole) vaginal gel to include treatment of bacterial vaginosis in females 12 years and older. Nuvessa was previously approved for use in adult females only.
  • Orkambi (lumacaftor/ivacaftor), now available as both oral tablets and granules, to include patients 2 years and older with cystic fibrosis who are homozygous for the F508del mutation in the CFTR gene. Orkambi was previously approved for this use only in patients 6 years and older.

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