FDA approves injectable antihistamine using BD Simplist
FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved a drug administered through a new line of injection devices made by BD, the company said Wednesday.
BD announced the approval of diphenhydramine hydrochloride injection, an antihistamine, packaged in its recently launched Simplist pre-filled injectables, which are made by subsidiary BD Rx and designed to improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence and thus reduce the potential risk of medication errors.
"We have made a significant investment in [research and development] and manufacturing capabilities to build a state-of-the-art manufacturing facility that combines drug formulation with our manufacturing expertise," BD EVP and COO William Kozy said. "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."
The company said that while traditional injections require up to 20 steps on the part of the physician, the Simplist requires about 12, in addition to featuring easy-to-read labels, bar-coding for easy identification and individually packaged, prefilled syringes.