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News You Can Use…

News You Can Use…. Jessica Binz, PharmD Pete Koval, PharmD Cone Health Family Medicine September 2014. New Drug Approval. Arnuity Ellipta - A once daily fluticasone dry powder inhaler For maintenance treatment of asthma Approved in 100mcg and 200mcg dosing system.

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News You Can Use…

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  1. News You Can Use… Jessica Binz, PharmD Pete Koval, PharmD Cone Health Family Medicine September 2014

  2. New Drug Approval • ArnuityEllipta- A once daily fluticasone dry powder inhaler • For maintenance treatment of asthma • Approved in 100mcg and 200mcg dosing system 8/20/14 FDA News and Events

  3. New Drug Approval • The FDA approved Belsomra (suvorexant) an orexin receptor antagonist • Approved for as needed treatment of insomnia • Doses: 5, 10, 15 and 20mg • Controlled substance (Schedule-IV) 8/13/14 FDA News Release

  4. Tentative Drug Approval • Lilly and Boehringer’s Basaglar (insulin glargine) received tentative approval by the FDA • A 30 month stay due to litigation filed by Sanofi (maker of Lantus). • FDA will not issue final approval until mid 2016, unless court finds in favor of Lilly earlier • Will be delivered through the KwikPen delivery system • Cheaper insulin glargine in 2016??? 8/18/2014 MarketWatch.com and Drugs@FDA

  5. FDA Advisory Committee Recommends Approval • Spiriva (tiopropium) with use of the Respimat device • Spiriva is currently available in the HandiHaler dry powder inhaler • FDA will rule at a later date 8/14/2014 MarketWatch

  6. In the News • An increased risk of cardiac death in those treated with clarithromycin vs penicillin V was seen in an observational study • 37 excess cardiac deaths/1 million • More studies needed to determine clinical relevance 8/19/2014 BMJ

  7. P&T Committee Approved items: • Auto substitution of select MDIs for nebulizer solutions 8/20/2014 Cone Health P&T

  8. MAP Changes • MAP will no longer dispense Novolog pens • Novolog VIALS ONLY when requesting Novolog from the MAP progam

  9. New Class II Controlled Substance • DEA will change all hydrocodone combination products to Schedule II controlled substances • Effective October 6, 2014 • Rxs written prior to 10/6/2014 will be honored for the duration of the Rx 8/22/14 deadiversion.usdoj.gov

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