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