1. Cone Health Family Medicine
News You Can Use…
Pete Koval, PharmD
Stacey Karl, PharmD
Cone Health Family Medicine
August 2014

2. 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/ FDA News and Events

3. 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/ MarketWatch.com

4. 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/ MarketWatch.com

5. 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/ FDA News and Events

6. 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/ FDA News and Events

7. 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/ MarketWatch.com

8. 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

9. 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 ;7968 and WSJ.com 7/23/14