BD (Becton, Dickinson and Company), a leading global medical technology company, announced that its wholly-owned subsidiary, BD Rx Inc. has received the US Food and Drug Administration (FDA) approval for the third drug to be offered in the new BD Simplist line of ready-to-administer prefilled generic injectables. The third BD Simplist product to launch is Ondansetron injection, USP 4mg/2mL (2mg/mL), an injectable antiemetic.

Ondansetron injection, USP which is used to prevent postoperative nausea and vomiting, is currently on the FDA drug shortage list due to recent demand increases and supply issues faced by other manufacturers. Ondansetron injection, USP also can be used with initial and repeat courses of emetogenic cancer chemotherapy.

“We’re proud to be expanding our BD Simplist products with a drug like Ondansetron injection, USP which is in high demand among clinicians and fills a need for an intervention that can be administered quickly,” said Mark Sebree, president, BD Rx. “As we establish our product line with a third drug approval, we are seeing even further indication of the positive response to our new BD Simplist prefilled injectables especially among repeat customers.”

In March, BD announced that it would be manufacturing generic pharmaceutical products for the first time through BD Rx. BD Rx also manufactures Metoclopramide injection, USP and Diphenhydramine hydrochloride injection, USP within the BD Simplist prefilled injectables line of products. 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.

The potential for medication error exists with every injection. Clinicians perform up to 20 steps in a traditional vial and syringe injection sequence. But with BD Simplist prefilled injectables, the injection sequence is reduced to approximately 12 steps, reducing the potential risk of medication error and allowing for more focus on the patient and less on injection preparation.

BD Rx plans to launch 20 to 30 drugs in its BD Simplist line of products during the next few years and is targeting generic injectables in doses most commonly relied on by clinicians in both the hospital and surgical center settings.

Ondansetron injection is a 5-HT3 receptor antagonist indicated for:
Prevention of nausea and/or vomiting postoperatively and with initial and repeat courses of emetogenic cancer chemotherapy.

Metoclopramide injection, USP is indicated for: the relief of symptoms associated with acute and recurrent diabetic gastric stasis; prophylaxis of vomiting associated with emetogenic cancer chemotherapy; the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.

Metoclopramide injection, USP also may be used to: facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers; stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.

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.