FDA Drug Approvals and Changes: January Edition

Contributor Information

Author

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

References

1. Guigliano RP, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104.
2. Hokusai-VTE Investigators, et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15.
3. Robert Lowes. FDA Approves Viekira Pak for Hepatitis C. Medscape Medical News. WebMD Inc. December 19, 2014. http://www.medscape.com/viewarticle/836981.
4. Kaufman B, et al. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol. Published online November 3, 2014. http://jco.ascopubs.org/content/early/2014/10/30/JCO.2014.56.2728.
5. Zerbaxa (ceftolozane/tazobactam) prescribing information. December 2014. Cubist Pharmaceuticals U.S. Lexington, MA.
6. Rapivab (peramivir) prescribing information. BioCryst Pharmaceuticals, Inc. Durham, NC. December 2014. http://rapivab.com/wp-content/uploads/2014/12/Rapivab-PI.pdf.
7. Opdivo (nivolumab) prescribing information. Bristol-Myers Squibb Company. Princeton, NJ. December 2014. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125554lbl.pdf.
8. Garon EB, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014 Aug 23;384(9944):665-73.
9. Yoo HK, et al. A multicenter, randomized, double-blind, placebo-controlled study of aripiprazole in children and adolescents with Tourette's disorder. J Clin Psychiatry. 2013 Aug;74(8):e772-80.
10. Abilify (aripiprazole) prescribing information. Otsuka America Pharmaceutical, Inc. Rockville, MD. December 2014. http://www.otsuka-us.com/products/Documents/Abilify.PI.pdf.
11. Caplin ME, et al. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014; 371:224-233.
12. Gadelha MR, et al. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2014 Nov;2(11):875-84.
13. FDA News Release: FDA approves weight-management drug Saxenda. December 23, 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427913.htm.
14. Stein L, et al. Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2014 Mar;13(3):316-23.
15. QNASL (beclomethasone dipropionate) Nasal Aerosol prescribing information. Teva Respiratory, LLC. Horsham, PA. December, 2014. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s007s009lbl.pdf.
16. Kalydeco (ivacaftor) prescribing information. Vertex Pharmaceuticals Inc. Boston, MA. December 2014. http://pi.vrtx.com/files/uspi_ivacaftor.pdf.
17. Gadavist (gadobutrol) prescribing information. Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ. December 29, 2014. http://labeling.bayerhealthcare.com/html/products/pi/gadavist_PI.pdf.
18. Daniels S, et al. Analgesic efficacy and safety of a novel injectable formulation of diclofenac compared with intravenous ketorolac and placebo after orthopedic surgery: a multicenter, randomized, double-blinded, multiple-dose trial. Clin J Pain. 2013 Aug;29(8):655-63.