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News You Can Use… Stacey Karl, PharmD Pete Koval, PharmD Cone Health Family Medicine January 2016 New Drug Approval • Basaglar® (insulin glargine) gained FDA approval for treatment of type 1 and type 2 diabetes • First insulin product approved through an abbreviated approval pathway • Trials proved that it was sufficiently similar to Lantus (insulin glargine) 12/16/2015 FDA.gov New Drug Approval • Zurampic® (lesinurad) gained FDA approval for treatment of hyperuricemia associated with gout, when used in combination with a xanthine oxidase inhibitor • Inhibits uric acid reabsorption in the kidney • Most common side effects include headache, increased SCr, and GERD 12/22/2015 FDA.gov New Drug Approval • QuilliChew® (methylphenidate ER) gained FDA approval for treatment of ADHD in patients ages 6 years old and above • First and only long-acting chewable methylphenidate treatment • Strengths: 20, 30, and 40 mg tablets 12/07/2015 Pfizer.com New Drug Approval • Uptravi® (selexipag) gained FDA approval for treatment of Pulmonary Arterial Hypertension (PAH) • Oral IP prostacyclin receptor agonist • Common side effects: headache, diarrhea, jaw pain, nausea/vomiting, myalgia, painful extremities, and flushing 12/22/2015 FDA .gov New Indication • Pradaxa® (dabigatran) gained FDA approval for the prevention of DVT and PE in patients undergoing hip replacement surgery • Also approved for treatment of PE/DVT, to lower the risk of recurrent PE/DVT in those previously treated, and to reduce the risk of stroke or systemic embolism in AFib 11/24/2015 Medscape.com Expanded Indication • Gardasil 9® (Human Papillomavirus 9- valent Vaccine, Recombinant) gained FDA approval for the prevention of anal cancer and genital warts in males 16 through 26 years old • Already approved for use in boys 9 -15 years old for the prevention of these diseases 12/15/2015 Merck.com REMS Program Lifted • The FDA is lifting the REMS program for Avandia® (rosiglitazone) and combination products • FDA reports that the REMS is no longer necessary to ensure that the benefits of the drug outweigh its risks 12/16/2015 FDA.gov New Guidelines • The CDC has posted new opioid guidelines open for public comment until January 13, 2016 • The guidelines recommend against opioid therapy for chronic pain and prefer nonpharmacologic treatment and nonopioid treatment 12/14/2015 CDC.gov New Study • A new study compared azithromycin vs doxycycline for urogenital chlamydia due to concern for decreased efficacy with azithromycin • Azithromycin was 97% effective and doxycycline was 100% in patients receiving directly observed therapy • Both still appropriate treatment options 12/24/2015 NEJM.com