News You Can Use…
Pete Koval, PharmD
Kim Mitchell, PharmD candidate
Cone Health Family Medicine
October 2014
New Drug Approval
• Contrave (bupropion/naltrexone)
received FDA approval for the treatment
of chronic weight management in
addition to reduced-calorie diet and
physical activity
• Patients lost an average of 4.1%
compared with placebo
• FYI – Trials for phenteramine/topiramate
had weight loss up to 9.3%
9/10/2014 FDA News and Events
New Drug Approval
• Spiriva Respimat (tiotropium) received
FDA approval as a maintenance
bronchodilator treatment to relieve
symptoms of patients with COPD
• DOSE: 2 inhalations 1x/day
2.5 mcg per inhalation
• Expected to be available
in January
9/26/2014 MedPage
New Drug Approval
• Ferric citrate (formerly Zerenex)
received FDA approval for control of
serum phosphorus levels in patients
with CKD on dialysis
• Effectively reduced serum phosphorus
levels to within KDOQI guidelines range of
3.5 mg/dL to 5.5 mg/dL
New Drug Approval
• Trulicity (dulaglutide), a weekly
GLP-1 receptor agonist gets FDA
approval for adults with type 2
diabetes as an adjunct to diet and
• Single-dose pen does not require
mixing nor measuring
• 0.75 mg and 1.5 mg dose syringes
• Launch by end of 2014
9/18/2014 CNN Money
New Drug Approval
• Keytruda (pembrolizumab) was
approved for treatment of patients with
advanced or unresectable melanoma
who are no longer responding to other
• Intended for use following treatment with
ipilimumab and, if needed, a BRAF inhibitor
• This is the first immunomodulator that acts as
program death (PD) inhibitor
9/4/2014 FDA News and Events
New Generic Available
• Mylan has launched Ibandronate
Sodium injection 1 mg/mL for the
treatment of osteoporosis in
postmenopausal women
• The injection will be packaged in 3mg/3mL
pre-filled glass syringes
New Indication
• Apixaban (Eliquis) has been FDA
approved for the treatment of DVT/PE
and for the reduction of risk of
recurrent DVT/PE following initial
• Treatment
• 10 mg PO BID X 7 day,
then 5 mg BID for total 6 months
• Reduce risk for recurrent DVT/PE
• 2.5 mg PO BID
• Renal adjustment – decrease dose by ½
Controlled Substance Change
• DEA change of
Hydrocodone/APAP to Schedule
II is effective TODAY, Oct. 6.
New NLA Cholesterol
• The National Lipid Association released new
recommendations for Patient-Centered
Management of Dyslipidemia
• The expert panel consensus emphasizes the
measure of non-HDL-C over the traditionally
reported LDL-C
• The intensity of risk reduction therapy should be
titrated to non-HDL-C goals adjusted to the
patient’s absolute risk for an ASCVD event
Journal of Clinical Lipidology 2014; 8: 473-488