FDA has approved Morphine Sulfate Injection, USP in the BD Simplist line of ready-to-administer prefilled injectables, reports BD Rx Inc., a wholly owned subsidiary of BD, in a release. Indicated for the management of pain not responsive to non-narcotic analgesics, Morphine Sulfate Injection will be supplied in 2 mg/mL, 4 mg/mL, 5 mg/mL, 8 mg/mL, and 10 mg/mL strengths.
BD Rx reports that it will begin morphine production immediately for projected availability early in 2014.
"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 Mark Sebree, President, BD Rx, in the release. "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."
With the BD Simplist prefilled injectable platform , the company has sought to decrease the number of steps in the traditional vial and syringe injection sequence in and effort to help "reduce the potential risk of medication error and allowing for more focus on the patient and less on injection preparation," it reports. "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."
Morphine Sulfate Injection, USP is the fourth in a series of 20 to 30 drugs that BD Rx plans to launch in the BD Simplist prefilled injectables product line. 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).
BD Rx is pursuing "the therapeutic categories primarily used by clinicians in the hospital and surgical center settings, including pain management, anesthetics, cardiovascular agents, and antiemetics," the company reports.
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