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BD (Becton, Dickinson and
Company)
, a leading global medical technology company, today
announced that the U.S. Food and Drug Administration (FDA) has approved the
first drug to be offered in the just-launched BD Simplist™
ready-to-administer, line of prefilled generic injectables. BD Simplist
prefilled injectables will be commercialized and manufactured by BD Rx Inc., a
wholly-owned subsidiary of BD. The first BD Simplist product BD Rx will
launch is Diphenhydramine Hydrochloride Injection, USP, an injectable
antihistamine.
(Photo: http://photos.prnewswire.com/prnh/20130327/NY84111 )
BD Simplist prefilled injectables are designed to help improve patient care
and safety by decreasing the number of steps in the traditional vial and
syringe injection sequence, reducing the potential risk of medication error.
"BD, a leading innovator in injection and infusion-based drug delivery,
continues to focus on providing innovative solutions to reduce the spread of
infection and advance drug delivery," said William A. Kozy, Executive Vice
President and Chief Operating Officer. "We have made a significant investment
in R&D and manufacturing capabilities to build a state-of-the-art
manufacturing facility that combines drug formulation with our manufacturing
expertise. BD is well positioned and uniquely suited to take this next step
based on our demonstrated, twelve-year history of continuous, reliable supply
of our Flush products and existing leadership position in prefillable syringe
manufacturing."
The potential for medication error exists with every injection. Clinicians
perform up to 20 steps in a traditional vial and syringe injection sequence,
which may increase the potential risk for error. With BD Simplist prefilled
injectables, the injection sequence is reduced to approximately twelve steps
allowing for more focus on the patient and less on injection preparation.
Additionally, BD Simplist prefilled injectables offer easy-to-read labels on
prefilled syringes, barcoding for easy identification and individually
packaged, prefilled syringes.
"The vial and syringe injection process is inefficient for healthcare
workers," said Mark Sebree, President, BD Rx. "With the new BD Simplist
ready-to-administer, prefilled injectables, BD is aiming to redefine
injectable drug administration practice. BD envisions safe patient care and
efficient clinical applications and believes this is the future of
injectables."
BD Rx plans to launch 20 to 30 drugs in BD Simplist prefilled injectables over
the next few years and is targeting injectable drugs in doses most commonly
relied on by clinicians in both the hospital and surgical center settings.
The financial impact of BD Simplist prefilled injectables for fiscal year 2013
will not be material and was contemplated in our fiscal year 2013 guidance.
About Diphenhydramine Hydrochloride Injection, USP
INDICATIONS AND USAGE
Diphenhydramine Hydrochloride Injection, USP is effective in adults and
pediatric patients, other than premature infants and neonates, when
Diphenhydramine Hydrochloride in the oral form is impractical.
For amelioration of allergic reactions to blood or plasma, in anaphylaxis as
an adjunct to epinephrine and other standard measures after the acute
symptoms have been controlled, and for other uncomplicated allergic conditions
of the immediate type when oral therapy is impossible or contraindicated. For
active treatment of motion sickness and for use in parkinsonism, when oral
therapy is impossible or contraindicated in the elderly who are unable to
tolerate more potent agents; mild cases of parkinsonism in other age groups,
and in other cases of parkinsonism in combination with centrally acting
anticholinergic agents.
IMPORTANT SAFETY INFORMATION
Diphenhydramine Hydrochloride is contraindicated in neonates, premature
infants, and as antihistamine therapy in nursing mothers and as a local
anesthetic and when a patient is hypersensitive to other antihistamines of
similar chemical structure.
Considerable caution should be used in patients with narrow-angle glaucoma,
stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic
hypertrophy, or bladder-neck obstruction.
Local necrosis has been associated with the use of subcutaneous or intradermal
use of the drug. It has an atropine-like action and, therefore should be used
with caution in patients with a history of bronchial asthma, increased
intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension
and in patients with lower respiratory disease including asthma.
It has additive effects with alcohol and other CNS depressants. MAO inhibitors
prolong and intensify the anticholinergic (drying) effects of antihistamines.
The most frequent adverse reactions are: Nervous System: sedation, sleepiness,
dizziness, disturbed coordination; GI System: epigastric distress; and
Respiratory System: thickening of bronchial secretions
Please see full prescribing information for additional important safety
information.
Conference Call Information
A conference call regarding the BD Simplist™ product line will be broadcast
live on BD's website, www.bd.com/investors, along with related slides, at 8:00
a.m. (ET) Thursday, March 28, 2013. The conference call will be available for
replay on BD's website, www.bd.com/investors, or at 1-800-585-8367 (domestic)
and 1-404-537-3406 (international) through the close of business on April 4,
2013, access code 28786781.
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