Transcript NEWS YOU CAN USE 2015 04 UPD

News You Can Use…
Pete Koval, PharmD
Lauren Hickman, PharmD Candidate
Cone Health Family Medicine
April 2015
New Drug Approval
• Toujeo (insulin glargine [rDNA origin]
injection, 300 U/ml), a once-daily long-acting
basal insulin, received FDA approval to treat
Type 1 and Type 2 diabetes
• Same active ingredient as Lantus, but at three
times the concentration and suggested to
have a design to release insulin more
gradually
• Lower rates of hypoglycemia were seen in
clinical trials by not mentioned in the FDAapproved label
02/25/2015 FDA News and Events
New Drug Approval
• Skyla (levonorgestrel-releasing IUD)
received FDA approval. The IUD
continuously releases levonorgestrel, a
progestin, to help prevent pregnancy for
up to three years.
• Mirena is the other levonorgestrel-releasing IUD.
Both products are made by Bayer.
• Skyla is smaller in size than Mirena, releases
less levonorgestrel (14 mcg/day vs. 20 mcg/day),
and is effective for a shorter period of time (3
years vs. 5 years).
03/02/2015 American Pharmacists Association
New Drug Approval
• Eylea (afilbercept): FDA approves new
treatment for diabetic retinopathy in
patients with diabetic macular edema
• An injection into the eye once a month for
the first five injections, then once every two
months
• Common side effects are bleeding of the
conjunctiva, eye pain, cataracts, floaters,
increased IOP, vitreous detachment, and
endophthalmitis
03/25/2015 FDA News and Events
New Drug Approval
• FDA approves first-in-class Glyxambi
(empagliflozin/linagliptin) tablets for
adults with type 2 diabetes
• Only SGLT2/DPP-4 inhibitor combination
to improve glycemic control as an adjunct
to diet and exercise
• As an add-on to metform, Glyxambi was
superior in reducing A1C when compared
with either empagliflozin or linagliptin
alone
03/24/2015 FDA News and Events
New Drug Approval
• FDA approves Jadenu (deferasirox), a
new formulation of Exjade (deferasirox)
to simplify treatment administration for
patients with chronic iron overload
• Jadenu is the only once-daily oral tablet for iron
chelation
• For patients with chronic iron overload due to
blood transfusions in patients 2 years of age
and older and in chronic iron overload in nontransfusion-dependent thalassemia syndromes
(NTDT) in patients 10 years of age and older
03/30/2015 Novartis
New Drug Approval
• FDA approves Elepsia XR
(levetiracetam) tablets for partial onset
in patients with epilepsy
• Extended release formulation will help to
decrease the pill burden for patients
• Supplied as 1000 mg and 1500 mg oncedaily tablets
• For patients of 12 years of age or older
03/04/2015 First Word Pharma
New Drug Approval
• FDA has approved albuterol sulfate
inhalation powder (ProAir RespiClick) for
the treatment or prevention of
bronchospasm in patients aged 12 years
and older with reversible obstructive
airway disease.
• Also approved for the prevention of
exercised-induced bronchospasm in patients
aged 12 years and older
• This is the first and only breath-actuated drypowder rescue inhaler.
04/02/2015 APhA Pharmacy Today
New Vaccine Approval
• Quadracel: FDA approves Sanofi’s new
vaccine that provides active immunization
against:
• Diptheria,Tetanus, Pertussis, and Poliomyelitis
• For children ages 4-6 years old
• A single dose of Quadracel is a approved as a
fifth dose in the DTaP series and as a fourth or
fifth dose in the inactivated poliovirus
vaccination (IPV) series, in children who have
received four doses of Pentacel and/or
DAPTACEL vaccine
03/24/2015 FDA Vaccines
Label Update
• FDA updates label for Chantix
(varenicline):
• Chantix can change the way people react to
alcohol (decreased tolerance, increased
drunkenness, unusual or aggressive
behavior, memory loss)
• Seizures occurred in patients that had no
history of seizures and in patients that had a
seizure disorder that had been well
controlled
03/09/2015 FDA Drug Safety