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Drug Updates

Michele B. Kaufman, PharmD, BCGP  |  Issue: September 2010  |  September 1, 2010

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

References

  1. Butrans transdermal system approved for chronic pain. www.empr.com/butrans-transdermal-system-approved-for-chronic-pain/article/173803. Published July 1, 2010. Accessed July 19, 2010.
  2. Purdue Pharma L.P. receives FDA approval for Butrans (buprenorphine) transdermal system CIII. www.purduepharma.com/pressroom/news/20100701.htm. Published July 1, 2010. Accessed July 19, 2010.
  3. Cipher achieves major milestone with FDA approval for CIP-TRAMADOL ER. www.cipherpharma.com/news/cipher-achieves-major-milestone-with-fda-approval-for-cip-tramadol-er. Published May 10, 2010. Accessed August 9, 2010.
  4. Perrone M. FDA clears Amgen’s bone-strengthening drug, Prolia. www.businessweek.com/ap/financialnews/D9G2P0400.htm. Published June 1, 2010. Accessed July 19, 2010.
  5. Oxsoralen-Ultra available again. www.empr.com/oxsoralen-ultra-available-again/article/173097. Published June 23, 2010. Accessed July 19, 2010.
  6. Rybic ODT. www.empr.com/rybix-odt/drugproduct/123. Published July 15, 2010. Accessed July 19, 2010.
  7. Watson’s Generic VALTREX 500 mg and 1000 mg receives FDA approval. http://ir.watson.com/phoenix.zhtml?c=65 778&p=irol-newsArticle&ID=1430538. Published May 24, 2010. Accessed August 9, 2010.
  8. Cadence Pharmaceuticals announces Ofirmev NDA action date of November 4, 2010. www.drugs.com/nda/ofirmev_100517.html. Published May 14, 2010. Accessed July 19, 2010.
  9. Dennis M.FDA grants priority review to Amgen’s Prolia to reduce skeletal events in patients with cancer. www.firstwordplus.com/Fws.do?articleid=26F40A2D5906449B805FADCBB79D447D. Published July 16, 2010. Accessed July 19, 2010.
  10. NDA submitted for DM-1796 for postherpetic neuralgia (PHN). www.empr.com/nda-submitted-for-dm-1796-for-postherpetic-neuralgia-phn/article/167056. Published March 31, 2010. Accessed July 19, 2010.
  11. FDA accepts NDA for Duexa for ulcer risk reduction in arthritis patients. www.empr.com/fda-accepts-nda-for-duexa-for-ulcer-risk-reduction-in-arthritis-patients/article/171054. Published May 26, 2010. Accessed July 19, 2010.
  12. Horizon Pharma, Inc. announces FDA acceptance of DUEXA New Drug Application for filing. www.prnewswire.com/news-releases/horizon-pharma-inc-announces-fda-acceptance-of-duexar-new-drug-application-for-filing-94915659.html. Published May 26, 2010. Accessed July 19, 2010.
  13. Teva R&D products auto-immune/inflammatory diseases and other. www.tevapharm.com/research/products_ai.asp. Accessed July 19, 2010.
  14. Teva to launch Laquinimod lupus clinical trial. www.tradingmarkets.com/news/stock-alert/teva_teva-to-launch-laquinimod-lupus-clinical-trial-the-firm-s-new-multiple-sclerosis-drug-may-be-able-t-850328.html. Published March 16, 2010. Accessed July 19, 2010.
  15. Laquinimod study in systemic lupus erythematosus (SLE) patients with active lupus arthritis. http://clinicaltrials.gov/ct2/show/NCT01085084. Published May 4, 2010. Accessed July 19, 2010.
  16. Phase 3 study of Lodotra for the treatment of rheumatoid arthritis (RA). www.empr.com/phase-3-study-of-lodotra-for-the-treatment-of-rheumatoid-arthritis-ra/article/172681. Published June 17, 2010. Accessed July 19, 2010.
  17. Dennis M. Regeneron’s Arcalyst meets main goal of late-stage gout trial. www.firstwordplus.com/Fws.do?articleid=DE0A30BB3ACE4F7E9A67BB3E517E588A. Published June 9, 2010. Accessed July 19, 2010.
  18. Update 1: Teva tests biosimilar version of Roche’s Rituxan. www.reuters.com/assets/print?aid=USLDE64O1UB20100525. Published May 25, 2010. Accessed July 19, 2010.
  19. Winston Laboratories, Inc. submits NDA for CIVANEX (Civamide Cream) for treatment of osteoarthritis. www.marketwatch.com/story/winston-laboratories-inc-submits-nda-for-civanexr-civamide-cream-for-treatment-of-osteoarthritis-2010-07-07. Published July 7, 2010. Accessed July 19, 2010.
  20. Petrochko C. Gout treatment gets label update for HIV drug interaction. www.medpagetoday.com/ProductAlert/DevicesandVaccines/19999. Published May 9, 2010. Accessed July 19, 2010.
  21. Peck P. Registry data point to diclofenac as deadliest NSAID. www.medpagetoday.com/Cardiology/Prevention/20558. Published June 8, 2010. Accessed July 19, 2010.
  22. Fosbøl, EL, Folke F, et al. Cause-specific cardiovascular risk associated with non-steroidal antiinflammatory drugs among healthy individuals. Circ Cardiovasc Qual Outcomes. 2010; 3:395-405.
  23. Arava (leflunomide): Boxed warning—risk of severe liver injury. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218912.htm?sms_ss=email. Published July 13, 2010. Accessed July 19, 2010.

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Filed under:Drug Updates Tagged with:ApprovalsDrugsPipline

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