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’srelated 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