Transcript NEWS YOU CAN USE 2015 02 UPD

News You Can Use…
Lauren Gray, PharmD Candidate
February 2015
New Drug Approval
• Bellafill®
received FDA approval for the treatment
of patients > 21 years of age with:
• moderate to severe atrophic, distensible
facial acne scars on the cheeks
• Works to treat acne scars by adding
volume to skin, lifting and smoothing pitted
acne scars leveling skin
01/07/15 FDA News and Events
New Drug Approval
• Savaysa™ (edoxaban) received FDA approval
to reduce the risk of stroke and systemic
embolism in patients with atrial fibrillation
that is unrelated to a heart valve problem.
Also indicated for treatment of DVT and PE in
patients who have completed 5-10 days of
therapy with a parenteral anticoagulant
• Black box warning stating to use alternative
anticoagulant in patients whose creatinine
clearance exceeds 95mL/min
• Oral factor Xa inhibitor
01/09/2015 FDA News and Events
New Drug Approval
• DUOPA™ (carbidopa/levodopa)
received FDA approval for the treatment
of motor fluctuations in people with
advanced Parkinson disease
• Drug delivered via a small portable
infusion pump
• Suspension goes through small intestines
via procedurally-placed tube
01/13/2015 FDA News and Events
New Drug Approval
• Rytary™ (carbidopa/levodopa ER)
received FDA approval for the treatment
of Parkinson’s disease, postencephalitic parkinsonism, and
parkinsonism that may follow carbon
monoxide intoxication or manganese
intoxication
• Starting dose: 23.75/95mg TID, may
increase to 36.25/145mg TID to QID
• Max dose 612.5 mg/2450mg
01/07/2015 FDA News and Events
Conversion of Immediate
Release carbidopa/levodopa to
Rytary
New Drug Approval
• Cosentyx™ (secukinumab) received
FDA approval for the treatment
moderate to severe plaque psoriasis in
adult patients who are candidates for
systemic therapy or phototherapy
• The most common side effects reported
was nasopharyngitis
01/21/2015 FDA News and Events
New Drug Approval
• Prestalia® (perindopril/amlodipine)
received FDA approval for treatment of
hypertension:
• In patients not adequately controlled with
monotherapy
• As initial therapy in patients likely to need
multiple drugs to achieve their blood
pressure goals
• Doses include: (perindopril/amlodipine)
3.5/2.5mg, 7/5mg, and 14/10mg
01/21/2015 FDA News and Events
Generic Approval
• Nexium (esomeprazole)
• Approved for generic manufacturing:
• Esomeprazole 20mg
• Esomeprazole 40mg
• Approved to treat GERD in adults and
children 1 year and older
• Continues to require prescription
• No release date available
01/26/2015 FDA News and Events
Update from Cone P & T
• 3 antibiotics were NOT recommended
for the Cone Health formulary:
• Tedizolid (Sivextro)
• Oritavancin (Orbactiv)
• Dalbavancin (Dalvance)