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News You Can Use… Robert Vincent, PharmD PGY1 Pete Koval, PharmD Cone Health Family Medicine September, 2016
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New Drug Approval Qbrelis ™ lisinopril oral solution First available ACE-I solution 1mg/ml strength Indicated for the treatment of: HTN in adults and children age ≥ 6 Adjunct therapy for heart failure Acute MI in adults http://silvergatepharma.com/index.php/2016/07/29/fda-approves-qbrelis-first-lisinopril-oral-solution-1-mgml-pediatric-patients-6-years
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New Drug Approval Troxyca ER ® (oxycodone/naltrexone) Indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment Formulated to deter abuse when crushed and administered orally or intranasally Not for PRN use http://www.pfizer.com/news/press-release
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New Vaccine Approval Afluria ® flu vaccine Inactivated influenza virus Available in quadrivalent (age 5 and up) and trivalent Trivalent formulation has Needleless injector Uses narrow fluid stream to penetrate skin Eligible age: 18-64 years Provides non-inferior immune response to traditional needle http://www.ptcommunity.com/news/2016-08-29-000000/fda-approves-afluria
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Investigational Drug Esketamine (s-katamine) receives two novel indications for the treatment of depression: Treatment-resistant depression Major depressive disorder with imminent risk of suicide Esketamine is a N-methyl-D-aspartate (NMDA) receptor antagonist NOT yet approved. Remains in studies for these two new novel indications. http://www.jnj.com/news/all/Esketamine-Receives-Breakthrough-Therapy-Designation
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Approved Biosimilars Erelzi ® (etanercept-szzs) biosimilar for Enbrel ® (etanercept) Indicated for ankylosing spondylitis, plaque psoriasis, psoriatic and rheumatoid arthritis Inflectra ® (infliximab-dyyb) biosimilar for Remicade ® (infliximab) Indicated for ankylosing spondylitis, plaque psoriasis, psoriatic and rheumatoid arthritis and UC/Crohn’s http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510362.htm
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Drug Prices Mylan to offer generic Epi-Pen at half the price Generic drug company (Mylan) offering “generic” of its own branded product $300 price tag (3x the 2007 price) and about ½ the price of the “brand name Epi-Pen” made by this same company http://www.nytimes.com/2016/08/30/business/mylan-generic-epipen.html?_r=1
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