FRANKLIN LAKES, N.J.
Nov. 4, 2013
BD Rx Inc.
, a wholly-owned subsidiary of leading global medical technology company BD (Becton, Dickinson and Company) (NYSE: BDX), announced today that the U.S. Food and Drug Administration (FDA) has approved Morphine Sulfate Injection, USP to be offered in the BD Simplist line of ready-to-administer prefilled injectables in the most common strengths: 2mg/mL, 4mg/mL, 5mg/mL, 8mg/mL and 10mg/mL. Morphine Sulfate Injection, USP is indicated for the management of pain not responsive to non-narcotic analgesics.
"The launch of an FDA approved morphine product at a time of heightened need is an important step in our plans to drive clinical practice improvements," said
, President, BD Rx. "The expansion of the BD Simplist product line demonstrates our commitment to providing our hospital and surgical center customers with drugs in high-demand today."
BD Rx will begin production of morphine immediately and projects initial product availability in early calendar year 2014.
This approval marks the fourth in a series of 20 to 30 drugs that BD Rx plans to launch in the BD Simplist prefilled injectables product line in the coming years. The first three drugs launched in the past year are Diphenhydramine Hydrochloride Injection, USP, Metoclopramide Injection, USP and Ondansetron Injection, USP 4mg/2mL (2mg/2mL). The company plans to focus on the therapeutic categories primarily used by clinicians in the hospital and surgical center settings, including pain management, anesthetics, cardiovascular agents and antiemetics.
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, helping to reduce the potential risk of medication error and allowing for more focus on the patient and less on injection preparation. Clinicians perform up to 20 steps in a traditional vial and syringe injection sequence. BD Simplist prefilled injectables reduce the injection sequence to approximately 12 steps.