News You Can Use… Stacey Karl, PharmD January 2015

New Drug Approval Zerbaxa™ (ceftolozane/tazobactam) received FDA approval for the treatment of adults with: complicated intra-abdominal infections (in addition to metronidazole) complicated urinary tract infections It is a combination of a cephalosporin and a beta-lactamase inhibitor 12/19/2014 FDA News and Events

New Drug Approval Viekira Pak™ (ombitasvir, paritaprevir, ritonavir, and dasabuvir) received FDA approval for the treatment of patients with chronic hepatitis C only approved for genotype 1 infection The most common side effects were fatigue, itching, weakness, nausea, and difficulty sleeping 12/19/2014 FDA News and Events

New Drug Approval Rapivab™ (peramivir) received FDA approval for the treatment of adults with the influenza infection It is a neuraminidase inhibitor It is administered as a one time IV dose The most common side effect is diarrhea 12/22/2014 FDA News and Events

New Drug Approval Soolantra® (ivermectin) received FDA approval for the treatment of inflammatory lesions, bumps, and pimples from rosacea Ivermectin has both anti-inflammatory and antiparasitic activity 12/24/2014 Medscape.com

New Drug Approval Xtoro® (finafloxacin otic suspension) received FDA approval for the treatment of acute otitis externa (swimmer’s ear) The most common side effects reported were itching and nausea 12/17/2014 FDA News and Events

New Drug Approval Saxenda® (liraglutide) received FDA approval for weight loss in addition to a reduced-calorie diet and physical activity It is approved for use in adults with BMI >30 or BMI >27 who have HTN, Type 2 DM, or dyslipidemia Doses include: 1.8mg and 3 mg 12/23/2014 FDA News and Events

New Drug Approval Gardasil 9® (Human Papillomavirus 9- valent Vaccine, Recombinant) received FDA approval prevention of certain disease cased by HPV It covers 5 more HPV types than Gardasil and has the potential to prevent ~90% of cervical, vulvar, vaginal and anal cancers Gardasil prevents ~70% 12/10/2014 FDA News and Events

New Drug Approval Namzaric® (memantine and donepezil) received FDA approval for the treatment of moderate-to-severe Alzheimer’s- related dementia It will be available in two strengths: Memantine/donepezil 28-10 mg Memantine/donepezil 14-10 mg 12/29/2014 ASHP Daily Briefing

New Drug Approval Dyloject® (diclofenac sodium) received FDA approval for the treatment of moderate-to-severe pain It is contraindicated for post-op pain in CABG patients, in moderate-to-severe renal insufficiency, and in those with a history of asthma, urticaria, or allergic reaction after taking aspirin or NSAIDs 12/31/2014 ASHP Daily Briefing

New Labeling Geodon® Ziprasidone has a new boxed warning for drug reaction with eosinophilia and systemic syndromes (DRESS) The FDA’s decision to add this warning is based on six cases of DRESS No fatalities due to DRESS have been reported with ziprasidone 12/11/2014 Reuters.com