1. News You Can Use…
Stacey Karl, PharmD
January 2015

2. 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/ FDA News and Events

3. 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/ FDA News and Events

4. 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/ FDA News and Events

5. 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/ Medscape.com

6. 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/ FDA News and Events

7. 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/ FDA News and Events

8. 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/ FDA News and Events

9. 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 mg
Memantine/donepezil mg
12/29/ ASHP Daily Briefing

10. 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/ ASHP Daily Briefing

11. 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