FDA Drug Approvals and Changes: November Edition

Mary L Windle, PharmD

November 21, 2014

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Contributor Information

Author

Mary L Windle, PharmD
Editor-in-Chief, Medscape Drug Reference

References

  1. Aapro M, et al. A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy. Ann Oncol. 2014 Jul;25(7):1328-33.
  2. Gralla RJ, et al. A phase III study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy. Ann Oncol. 2014 Jul;25(7):1333-9.
  3. Afdhal N, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93.
  4. Afdhal N, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98.
  5. Kowdley KV, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014 May 15;370(20):1879-88.
  6. King TE, et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2083-92.
  7. Noble PW, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011 May 21;377(9779):1760-9.
  8. Richeldi L, et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82.
  9. FDA News Release: First vaccine approved by FDA to prevent serogroup B meningococcal disease. October 29, 2014. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm420998.htm.
  10. Lumason (sulfur hexafluoride lipid-type A microspheres) prescribing information. Bracco Diagnostics, Inc.; Monroe Twp., NJ. October 29, 2014. Available at: http://imaging.bracco.com/sites/braccoimaging.com/files/technica_sheet_pdf/Lumason-Final-PI-labeling-10-29-14_0.pdf
  11. Cymbalta (duloxetine) prescribing information. Lilly USA, LLC .Indianapolis, IN. October 23, 2014 . Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s043s044lbl.pdf
  12. Obizur (antihemophilic factor [recombinant], porcine sequence). Baxter Healthcare Corp. Westlake Village, CA. October 2014. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM420173.pdf
  13. Uceris Rectal Foam (budesonide) prescribing information. Distributed by Salix Pharmaceuticals, Inc. (under license from Dr. Falk Pharma);.Raleigh, NC. October 8, 2014 . Available at: https://81b77e9a9bc9711e90b1-f416dd7f832b6e1ad8c969a90667ca99.ssl.cf1.rackcdn.com/shared/pi/uceris-rectal-foam-pi.pdf