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Drug Updates

Michele B. Kaufman, PharmD, BCGP  |  Issue: May 2011  |  May 16, 2011

Michele Kaufman is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

  1. U.S. Food and Drug Administration. FDA approves Benlysta to treat lupus. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm246489.htm. Published March 9, 2011. Accessed March 31, 2011.
  2. Prolia (denosumab) open-label extension trial showed continued increase in bone mineral density over five years of treatment with similar safety profile observed in pivotal trial. www.prnewswire.com/news-releases/prolia-denosumab-open-label-extension-trial-showed-continued-increase-in-bone-mineral-density-over-five-years-of-treatment-with-similar-safety-profile-observed-in-pivotal-trial-118528339.html. Published March 23, 2011. Accessed March 31, 2011.
  3. NICE recommends golimumab for the treatment of psoriatic arthritis. www.medicalnewstoday.com/articles/219418.php. Published March 18, 2011. Accessed March 31, 2011.
  4. National Institute for Health and Clinical Excellence. Final appraisal determination: Golimumab for the treatment of psoriatic arthritis. www.nice.org.uk/nicemedia/live/12411/53514/53514.pdf. Published March 11, 2011. Accessed March 31, 2011.
  5. National Institute for Health and Clinical Excellence. Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis. www.nice.org.uk/nicemedia/live/13110/50422/50422.pdf. Published August 2010. Accessed March 31, 2011.
  6. FDA approves Exalgo extended-release tablets. http://phx.corporate-ir.net/preview/phoenix.zhtml?c=148036&p=irol-newsArticle&ID=1397339&highlight=. Published March 2, 2011. Accessed March 31, 2011.
  7. Exalgo product label. www.accessdata.fda.gov/drugsatfda_docs/label/2010/021217lbl.pdf. Published March 1, 2010. Accessed March 31, 2011.
  8. U.S. Food and Drug Administration. March 24, 2011 Approval Letter–Zostavax. www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm248608.htm. Published March 24, 2011. Accessed March 31, 2011.
  9. FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age. www.prnewswire.com/news-releases/fda-approves-zostavax-vaccine-to-prevent-shingles-in-individuals-50-to-59-years-of-age-118599704.html. Published March 24, 2011. Accessed March 31, 2011.
  10. Phase 3 trial of oral calcitonin for postmenopausal osteoporosis. www.empr.com/phase-3-trial-of-oral-calcitonin-for-postmenopausal-osteoporosis/article/199047/. Published March 24, 2011. Accessed March 31, 2011.
  11. ARCALYST (rilonacept) meets primary and all secondary endpoints in second phase 3 trial for prevention of gout flares in patients initiating uric acid-lowering therapy. http://files.shareholder.com/downloads/REGN/1184217156x0x445080/2c888b31-700d-4ae6-97a1-392d32134573/REGN_News_2011_ 2_28_General_Releases.pdf. Published February 28, 2011. Accessed March 31, 2011.
  12. Pfizer’s rheumatoid arthritis drug tofacitinib meets goals of Phase III trial. www.firstwordplus.com/Fws.do?articleid=625F47EE3E1C46339D74E78735F70F15&logRowId=402911. Published March 4, 2011. Accessed March 31, 2011.
  13. Gever J. Morphine combo pain drug recalled. www.medpagetoday.com/ProductAlert/Prescriptions/25344. Published March 15, 2011. Accessed March 31, 2011.
  14. ASHP Expert Panel On Drug Product Shortages et al. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009;66:1399-1406.
  15. Understanding and Managing Drug Shortages, 37th ASHP Midyear Clinical Meeting, Atlanta, GA, December 9, 2002. www.ashp.org/s_ashp/docs/files/DShort_abbott_drug.pdf. Accessed March 31, 2011.
  16. U.S. Food and Drug Administration. Drug shortages, drug information rounds, December 1, 2010. www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm235347.htm. Accessed March 31, 2011.
  17. ASHP Drug Product Shortages Management Resource Center. www.ashp.org/DrugShortages/Current. Accessed March 31, 2011.

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Filed under:AnalgesicsDrug Updates Tagged with:ApprovalsDrugsFDAPipelineSafetyshortage

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