Download NEWS YOU CAN USE 2014 08 UPD

News You Can Use…
Pete Koval, PharmD
Stacey Karl, PharmD
Cone Health Family Medicine
August 2014
New Drug Approval
• Striverdi Respimat (olodaterol
Respimat) received FDA approval for
the treatment of COPD
• Long-acting beta-adrenergic agonist
(LABA)
FYI - Spiriva is due to lose patent
protection soon … a once-daily
combination of olodaterol and
tiotropium is being investigated
7/31/2014 FDA News and Events
New Drug Approval
• Kerydin (tavaborole) 5% topical solution
received FDA approval for the topical
treatment of onychomycosis of the
toenail
• It is the first oxaborole antifungal approved
for this indication
• Apply to affected toenails once daily for 48
weeks
7/8/2014 MarketWatch.com
New Drug Approval
• Rasuvo (methotrexate) subcutaneous
injection received FDA approval for the
treatment of RA, poly-articular-course
juvenile idiopathic arthritis (pJIA), and
psoriasis
• It will be available in 10 dosage strengths,
ranging from 7.5 mg to 30 mg in 2.5 mg
increments
7/14/2014 MarketWatch.com
New Drug Approval
• Ruconest (C1 esterase inhibitor
[recombinant]) received FDA approval
for the treatment of acute attacks in
adult and adolescent patients with
hereditary angioedema
• It is the first recombinant C1-Esterase
Inhibitor product
7/17/2014 FDA News and Events
New Drug Approval
• Targiniq ER (oxycodone + naloxone)
received FDA approval for the treatment
of pain severe enough to require daily,
around-the-clock, long-term opioid
treatment
• This combination is designed to be hard to
abuse
7/23/2014 FDA News and Events
New OTC Approval
• Flonase (fluticasone) received FDA
approval as an OTC treatment for all
nasal and eye-related allergy symptoms
• It will be available as the 50mcg per spray
prescription strength
• Note: This is the 2nd OTC nasal steroid
Triamcinolone (Nasacort) – approved 10/2013
7/24/2014 MarketWatch.com
New Controlled Substance
• DEA will change Ultram®
tramadol to a Class IV substance
• Effective as of August 18th, 2014
7/2/14 deadiversion.usdoj.gov
In the News
• Blood level monitoring and dose adjustment for
Pradaxa (dabigatran) could reduce major bleeding
risk by as much as 20% compared to unadjusted use,
according to company documents found by BMJ
• The drug company disputed the BMJ findings, saying
“…scientific evidence does not support dosing
decisions for Pradaxa based on blood levels."
• Patients may be concerned as this has been in the
news
• The FDA has yet to comment
BMJ 2014.349;7968 and WSJ.com 7/23/14