FDA Drug Approvals and Changes: February Edition

Mary L Windle, PharmD

February 20, 2015


Contributor Information


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


  1. Finn RS, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35.
  2. Langley RG, et al. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. http://www.nejm.org/doi/full/10.1056/NEJMoa1314258.
  3. Gupta A. Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (PRIME). Presented at the 34th Annual Dialysis Conference in Atlanta, GA. February 8-11, 2014.
  4. Triferic (ferric pyrophosphate) prescribing information. Rockwell Medical, Inc. Wixom, MI. January 2015.
  5. McElroy SL, et al. Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder. JAMA Psychiatry. January 14, 2015. http://archpsyc.jamanetwork.com/article.aspx?articleid=2089519.
  6. Treon SP, et al. A prospective multicenter study of the Bruton's tyrosine kinase inhibitor ibrutinib in patients with relapsed or refractory Waldenström's macroglobulinemia (abstract 251). Presented at the 55th American Society of Hematology Annual Meeting and Exposition. New Orleans, LA. December 7-10, 2013.
  7. Mannstadt M, et al. Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomised, phase 3 study. Lancet Diabetes Endocrinol. 2013 Dec;1(4):275-83.
  8. FDA News Release. FDA approves a second vaccine to prevent serogroup B meningococcal disease. January 23, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431370.htm.
  9. Prezcobix (darunavir/cobicistat) prescribing information. Janssen Pharmaceuticals. Titusville, NJ. January 2015. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205395s000lbl.pdf.
  10. Evotaz (atazanavir/cobicistat) prescribing information. Bristol-Myers Squibb Co., Princeton, NJ. January 2015. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206353s000lbl.pdf.
  11. Olanow CW, et al. Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson's disease: a randomised, controlled, double-blind, double-dummy study. Lancet Neurol. 2014 Feb;13(2):141-9.
  12. Prestalia (perindopril/amlodipine) prescribing information. Symplmed, LCC. Cincinnati, OH. January 2015. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205003s000lbl.pdf.