2014 in Review: Important Drug Changes You Should Know

Mary L Windle, PharmD

December 26, 2014

Previous
 of 
Next

Contributor Information

Author

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

References

  1. Jenkins, JK. CDER New Drug Review: 2014 Update. United States Food and Drug Administration (FDA). December 11, 2014. Available at: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm074833.htm
  2. 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.
  3. Afdhal N, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98.
  4. 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.
  5. A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome). NCT01275066. Available at: http://clinicaltrials.gov/ct2/show/study/NCT01275066?term=MOR-004&rank=1
  6. Koch A, et al. Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat® versus placebo and formoterol twice daily in patients with GOLD 2-4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014 Jul 5;9:697-714
  7. Ferguson GT, et al. Efficacy and safety of olodaterol once daily delivered via Respimat® in patients with GOLD 2-4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014 Jun 16;9:629-45
  8. Cerdelga (eliglustat) prescribing information [package insert]. IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland: Genzyme Ireland, Ltd.; August 2014. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205494Orig1s000lbl.pdf
  9. Calabresi PA, et al. Pegylated interferon β-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. Lancet Neurol. 2014 Jul;13(7):657-65
  10. FDA News Release: FDA approves Viekira Pak to treat hepatitis C. December 19, 2014. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427530.htm.
  11. Kaufman B, et al. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol. 2014 Nov 3 [Epub ahead of print].
  12. Available at: FDA News Release: FDA approves new antibacterial drug Zerbaxa. December 19, 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427534.htm
  13. Rapivab (peramivir) prescribing information. BioCryst Pharmaceuticals, Inc. Durham, NC. December 2014. http://rapivab.com/wp-content/uploads/2014/12/Rapivab-PI.pdf