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.
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.
BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs nearly 30,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public.
Source: BD