First drug in BD Simplist family of products approved by US FDA
BD (Becton, Dickinson and Company), a global medical technology company, has received US FDA approval for the first drug in its BD Simplist line of prefilled syringes containing generic injectables.
The injectable antihistamine Diphenhydramine Hydrochloride Injection, USP will be the first product to be launched by BD subsidiary, BD Rx, which will focus on commercialising and manufacturing prefilled injectables.
BD Rx says it plans to launch 20 to 30 BD Simplist prefilled injectables over the next few years.
‘With the new BD Simplist ready-to-administer, prefilled injectables, BD is aiming to redefine injectable drug administration practice,’ said Mark Sebree, President of BD Rx.
‘BD envisions safe patient care and efficient clinical applications and believes this is the future of injectables.’
The company says the BD Simplist prefilled injectables decrease the number of steps in the traditional vial and syringe injection sequence, reducing the potential risk of medication error.
William Kozy, BD’s Executive Vice President and Chief Operating Officer, added: ‘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, 12-year history of continuous, reliable supply of our Flush products and existing leadership position in prefillable syringe manufacturing.’