1. News You Can Use… Stacey Karl, PharmD Pete Koval, PharmD Cone Health Family Medicine August 2015

2. New Drug Approval Entresto (sacubitril/valsartan) gained FDA approval for the treatment of heart failure in patients with NYHA Class II-IV and reduced ejection fraction It is to be used in the place of an ACE inhibitor or ARB The target dose is 97/103 mg BID 07/07/2015 FDA.gov

3. New Drug Approval Praluent (alirocumab), a PCSK9 inhibitor, gained FDA approval for the treatment of adults with heterozygous familial hypercholesterolemia or patients with clinical atheroschlerotic cardiovascular disease It is to be used in addition to diet and maximally tolerated statin therapy 07/24/2015 FDA.gov

4. New Drug Approval Rexulti (brexpiprazole) gained FDA approval for the treatment of adults with schizophrenia and as an add-on treatment to antidepressant therapy in adults with MDD Black box warning: increased risk of death associated with the off-label use to treat dementia-related psychosis 07/13/2015 FDA.gov

5. New Drug Approval Daklinza (daclatasvir) gained FDA approval for use with sofosbuvir to treat hepatitis C virus genotype 3 infections Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 without the need for co-administration of interferon or ribavirin 07/24/2015 FDA.gov

6. Generic Approval Almotriptan, generic for Axert, is now available Almotriptan is indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura Available as 6.25 mg and 12.5 mg tablets 07/11/2015 Pharmacy Times

7. Generic Approval Metformin/repaglinide, generic for Prandimet, is now available Metformin/repaglinide is indicated for the treatment of type two diabetes Available as 500mg/1mg tablets and 500/2mg tablets 07/15/2015 FDA.gov

8. Trial Review RE-VERSE trial shows idarucizumab completely reversed the anticoagulant effects of dabigatran Patients who were included had serious bleeding or required urgent procedures The median investigator-reported time to the cessation of bleeding was 11.4 hours Dilute thrombin time and ecarin clotting time was used to determine reversal 06/22/2015 N Engl J Med

9. FDA Warning FDA issued a warning of increased risk of myocardial infarction or stroke for NSAIDs The risk of MI or stroke can occur as early as the first weeks of using an NSAID The risk appears great at higher doses The risk is also increased in patients without heart disease or risk factors 07/09/2015 FDA.gov