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In July 2014, several new drugs received FDA approval to address various medical conditions. Dalvance (dalbavancin) was approved for IV treatment of MRSA skin infections with a two-dose regimen one week apart. Sivextro (tedizolid) is approved for skin infections caused by MRSA in both IV and oral formulations, requiring daily dosing for six days. Afrezza (inhalation insulin) offers a rapid-acting option for diabetes management, while Jublia (efinaconazole) is a topical solution for onychomycosis. Nasocobal (B12 nasal spray) also received approval, providing convenient dosing.
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News You Can Use… Pete Koval, PharmD Lauren Bajbus, PharmD Cone Health Family Medicine July 2014
New Drug Approval • Dalvance (dalbavancin) received FDA approval for IV use in the treatment of MRSA skin and soft tissue infections • Course of therapy would require 2 doses given 1 week apart 6/4/2014 FDA News & Events
New Drug Approval • Sivextro (tedizolid) - approved for skin and soft tissue infections caused by MRSA • IV and PO formulations will be available • Daily dosing x 6 days 6/20/2014 Bloomberg News
New Drug Approval • Afrezza (insulin human) inhalation powder approved for use in adults with diabetes • Rapid-acting orally inhaled insulin • Administered at the beginning of each meal 6/27/2014 FDA News & Events
New Drug Approval • Jublia (efinaconazole) approved for the treatment onychomyosis of the toenail • 10% topical solution • Apply once daily to clean dry toenails. Wait for at least 10 minutes after showering, bathing, or washing before applying. Use for 24-48 weeks… 6/12/2014 FDA News & Events
New Drug Approval • Nasocobal (B12 supplementation nasal spray) approved by FDA • Single-use devices for which the dosing is 500mcg (one spray) once weekly • New DEVICE… “our new single-use device does NOT require priming…eliminates product loss…permits patients to conveniently receive their dose with one spray per disposable device” 6/11/2014 Drug Store News
New Generic Approval • Actonel (risdendronate sodium) 150mg • Mylan will begin marketing this new generic 6/11/2014 Drug Store News
New Clinical Findings • Around 30% of patients taking an OTCPPI are not taking them correctly (ie before breakfast) and are not achieving benefit • Survey of 610 patients • 190 received prescriptions from GI- 71% used correctly • 223 received prescriptions from PCP- 47% used correctly • 197 purchased OTC- 39% used correctly American Journal of Gastroenterology. 2014; 109: 789-794
New Clinical Finding • Metformin may benefit African Americans more than “European Americans” • A1c percentages decreased more in African American individuals • Unsure if this translates to less complications from diabetes 6/12/2014 Journal of Clinical Endocrinology and Metabolism